Gastric Procedures, Lung Resection Procedures
Conditions
Keywords
Buttress, gastrectomy, gastric bypass, lung volume reduction
Brief summary
This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ECHELON ENDOPATH Staple Line Reinforcement instructions for use.
Detailed description
The primary objective of this study is to prospectively generate clinical data on device-related adverse events in a post-market setting using ECHELON ENDOPATH Staple Line Reinforcement per its instructions for use. There will be no blinding in this study. An interim analysis is planned for sample-size re-estimation.
Interventions
ENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use.
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary procedure (gastric or lung resection) where the ECHELON SLR is planned to be used for reinforcement of staple lines per the IFU in either a or b: 1. Gastric procedures limited to laparoscopic gastric resection, robotic laparoscopic gastric resection, partial gastrectomy, gastric wedge resection, subtotal gastrectomy, laparoscopic Roux-en-Y gastric bypass, and robotic laparoscopic gastric bypass; or 2. Lung resection procedures that include lobectomy, segmentectomy or wedge resection, and lung volume reduction surgery, and may be video assisted thoracic surgery (VATS) or open procedures; * Willingness to give consent and comply with all study-related evaluations and visit schedule; and * At least 18 years of age.
Exclusion criteria
\- Preoperative: 1. Physical or psychological condition which would impair study participation; 2. Body mass index (BMI) ≥ 46.0 kg/m2; 3. The procedure is a revision/reoperation for the same indication or same anatomical location; 4. A procedure where extended wound or organ support is required; 5. Any medical condition that the investigator deems could impact inflammatory or immune response; 6. Concurrent treatment with medications that the investigator deems could have influence on wound healing; 7. History of hypersensitivity to polyglactin (Vicryl®), Polydioxanone (PDO or PDS), or hypersensitivity to related products (cross-allergy); or 8. Enrollment in a concurrent interventional clinical study that could impact the study endpoints. * Intraoperative: 9. Per surgeon discretion, presence of adhesions that could lead to an increased risk of leak occurrence at a different location than the staple line.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures | From Day 0 (day of surgery) through 70 days post-surgery | Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line). |
| Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days | From Day 0 (day of surgery) through 70 days post-surgery | Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Study Devices Replaced During Surgery | Day 0 (Intra-surgery) | Number of study devices replaced during surgery due to slipping or bunching or not properly loaded onto stapler cartridge, Other - preloaded wrong color cartridge, Other- SLR added before cartridge, Other- dropped on the ground was reported. |
| Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Day 0 (Intra-surgery) | Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions experienced less manipulation or movement compared to previous device, experienced greater confidence the device will deliver best result compared to previous device, experienced greater confidence in simplicity of set up compared to previous device, experienced less frustration with device compared to previous device, experienced less waste compared to previous device, Likely to recommend to a colleague. Each question response was ranged from 1 to 5 where 1=strongly disagree, 2=slightly disagree,3=neutral, 4=slightly agree, 5= strongly agree, where the higher response signified good experience on the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and 5th procedure were reported. |
| Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Day 0 (Intra-surgery) | Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions satisfaction of operative flow compared to previous device and satisfaction of manipulation and repositioning compared to previous device and each question response was ranged from 1 to 5 where 1=very dissatisfied, 2=dissatisfied, 3=neither dissatisfied nor satisfied (NDNS), 4=satisfied, 5=very satisfied, where higher response signified good satisfaction with the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and fifth procedure were reported. |
Countries
United States
Participant flow
Recruitment details
Participants who planned to have an elective gastric or lung resection surgical procedure were recruited in the study.
Pre-assignment details
Participants were screened anytime during a period of 8 weeks prior to the date of surgery.
Participants by arm
| Arm | Count |
|---|---|
| Gastric Participants Gastric participants were treated with at least one ECHELON ENDOPATH Staple Line Reinforcement (SLR) during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. | 109 |
| Thoracic Participants Thoracic participants were treated with at least one ECHELON ENDOPATH SLR during elective resection procedure and were followed post-operatively through discharge and at post-surgery through 70 days. | 131 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 11 | 7 |
| Overall Study | Other | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Thoracic Participants | Total | Gastric Participants |
|---|---|---|---|
| Age, Continuous | 62.8 Years STANDARD_DEVIATION 12 | 54.9 Years STANDARD_DEVIATION 14.5 | 45.5 Years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 8 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 122 Participants | 221 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 27 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 15 Participants | 7 Participants |
| Race (NIH/OMB) White | 108 Participants | 193 Participants | 85 Participants |
| Sex: Female, Male Female | 73 Participants | 164 Participants | 91 Participants |
| Sex: Female, Male Male | 58 Participants | 76 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 2 / 131 |
| other Total, other adverse events | 74 / 109 | 116 / 131 |
| serious Total, serious adverse events | 8 / 109 | 18 / 131 |
Outcome results
Primary
Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures
Number of participants who experienced specific device-related AEs post gastric resection procedures was reported. Specific device-related AEs were bleeding (defined as occurrence of post-surgery blood transfusion deemed related to bleeding at the staple line or return to surgery room before 70-day post-surgery follow-up visit due to bleeding deemed related to the staple line), leak (defined as occurrence of intra-surgery or post-surgery gastrointestinal leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically), and stricture (defined as occurrence of stricture documented radiographically or by endoscopy along the staple line).
Time frame: From Day 0 (day of surgery) through 70 days post-surgery
Population: The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure and completed the study through 70-days. Here, N' (number of participants analyzed) signifies the participants who were evaluable for this outcome measure. This outcome measure was planned to be analyzed for specified arm only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gastric Participants | Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures | Bleeding | 0 Participants |
| Gastric Participants | Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures | Leak | 1 Participants |
| Gastric Participants | Number of Participants Who Experienced Specific Device-related Adverse Events (AEs) Through 70 Days Post Gastric Resection Procedures | Stricture | 0 Participants |
Primary
Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days
Number of participants who experienced specific device-related AEs post lung resection procedures was reported. Specific device related AEs were prolonged air leak (occurrence of intra-surgery or post-surgery lung leak related to the staple line as documented intra-surgery, by clinical exam, or radiographically) deemed related to the staple line (greater than post-surgery Day 7), and empyema (defined as purulent fluid collection in the pleural space documented radiographically, excluding chronic empyema).
Time frame: From Day 0 (day of surgery) through 70 days post-surgery
Population: The analysis set included all participants in whom the ECHELON SLR was utilized during the surgical procedure and completed the study through 70-days. This outcome measure was planned to be analyzed for specified arm only.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gastric Participants | Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days | Prolonged air leak | 0 Participants |
| Gastric Participants | Number of Participants Who Experienced Specific Device-related Adverse Events Through 70 Days | Empyema | 0 Participants |
Secondary
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback
Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions experienced less manipulation or movement compared to previous device, experienced greater confidence the device will deliver best result compared to previous device, experienced greater confidence in simplicity of set up compared to previous device, experienced less frustration with device compared to previous device, experienced less waste compared to previous device, Likely to recommend to a colleague. Each question response was ranged from 1 to 5 where 1=strongly disagree, 2=slightly disagree,3=neutral, 4=slightly agree, 5= strongly agree, where the higher response signified good experience on the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and 5th procedure were reported.
Time frame: Day 0 (Intra-surgery)
Population: The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies the number of investigators who responded to device questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress:Strongly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous: Slightly agree | 2 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress:Slightly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Slightly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress: Neutral | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly agree | 1 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress: Slightly agree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress: Strongly agree | 12 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Strongly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Strongly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Slightly agree | 6 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Slightly disagree | 1 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Slightly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Neutral | 1 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous:Slightly disagree | 3 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Slightly agree | 4 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Neutral | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Strongly agree | 6 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Neutral | 3 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Strongly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Slightly agree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Slightly disagree | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous: Neutral | 6 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Neutral | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Strongly agree | 12 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Slightly agree | 5 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Strongly agree | 3 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Strongly agree | 7 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Strongly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Strongly agree | 16 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Strongly disagree | 1 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Slightly disagree | 1 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Neutral | 1 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Slightly agree | 2 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Experienced less buttress manipulation and movement compared to previous buttress: Strongly agree | 13 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous:Slightly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous: Neutral | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous: Slightly agree | 2 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Greater confidence that SLR buttress deliver best outcomes compared to previous: Strongly agree | 16 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Strongly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Slightly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Neutral | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Slightly agree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | SLR setup simplifies concerns compared to previous buttress product: Strongly agree | 18 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress:Strongly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress:Slightly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress: Neutral | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress: Slightly agree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Surgical staff experienced less frustration with SLR compared to previous buttress: Strongly agree | 18 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Strongly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Slightly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Neutral | 2 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Slightly agree | 2 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Foresee less waste of SLR compared to the previous buttress: Strongly agree | 14 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Strongly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Slightly disagree | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Neutral | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Experience Feedback | Likely to recommend to a colleague: Slightly agree | 2 Investigators |
Secondary
Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback
Investigators were asked to answer a non-validated device questionnaire related to his/her experience using the ECHELON SLR. Questionnaire included following questions satisfaction of operative flow compared to previous device and satisfaction of manipulation and repositioning compared to previous device and each question response was ranged from 1 to 5 where 1=very dissatisfied, 2=dissatisfied, 3=neither dissatisfied nor satisfied (NDNS), 4=satisfied, 5=very satisfied, where higher response signified good satisfaction with the device. In this outcome measure, device questionnaire responses which were provided by selected investigators after the site's first, third, and fifth procedure were reported.
Time frame: Day 0 (Intra-surgery)
Population: The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure. Here, N' (number of participants analyzed) signifies the number of investigators who responded to device questionnaire.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Very dissatisfied | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Dissatisfied | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Neither dissatisfied nor satisfied | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Satisfied | 3 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Very satisfied | 9 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device:Very dissatisfied | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device: Dissatisfied | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device: NDNS | 0 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device: Satisfied | 1 Investigators |
| Gastric Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device: Very satisfied | 11 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device: NDNS | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Very dissatisfied | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device:Very dissatisfied | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Dissatisfied | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device: Very satisfied | 15 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Neither dissatisfied nor satisfied | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device: Dissatisfied | 0 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Satisfied | 2 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of manipulation and repositioning compared to previous device: Satisfied | 3 Investigators |
| Thoracic Participants | Device Usability Evaluation by Surgeon Questionnaire: Investigator's Device Satisfaction Feedback | Satisfaction of operative flow compared to previous device: Very satisfied | 16 Investigators |
Secondary
Number of Study Devices Replaced During Surgery
Number of study devices replaced during surgery due to slipping or bunching or not properly loaded onto stapler cartridge, Other - preloaded wrong color cartridge, Other- SLR added before cartridge, Other- dropped on the ground was reported.
Time frame: Day 0 (Intra-surgery)
Population: The analysis set included all participants in whom the ECHELON SLR is utilized during the surgical procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gastric Participants | Number of Study Devices Replaced During Surgery | Slipping | 0 Replaced study devices |
| Gastric Participants | Number of Study Devices Replaced During Surgery | Bunching | 0 Replaced study devices |
| Gastric Participants | Number of Study Devices Replaced During Surgery | Not Loaded Properly | 7 Replaced study devices |
| Gastric Participants | Number of Study Devices Replaced During Surgery | Other - Preloaded Wrong Color Cartridge | 1 Replaced study devices |
| Gastric Participants | Number of Study Devices Replaced During Surgery | Other- SLR Added Before Cartridge | 1 Replaced study devices |
| Gastric Participants | Number of Study Devices Replaced During Surgery | Other- Dropped on the Ground | 1 Replaced study devices |
| Thoracic Participants | Number of Study Devices Replaced During Surgery | Other- SLR Added Before Cartridge | 0 Replaced study devices |
| Thoracic Participants | Number of Study Devices Replaced During Surgery | Slipping | 3 Replaced study devices |
| Thoracic Participants | Number of Study Devices Replaced During Surgery | Other - Preloaded Wrong Color Cartridge | 0 Replaced study devices |
| Thoracic Participants | Number of Study Devices Replaced During Surgery | Bunching | 1 Replaced study devices |
| Thoracic Participants | Number of Study Devices Replaced During Surgery | Other- Dropped on the Ground | 0 Replaced study devices |
| Thoracic Participants | Number of Study Devices Replaced During Surgery | Not Loaded Properly | 3 Replaced study devices |