Upper GI; Lower GI; Gynecological
Conditions
Brief summary
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal \[GI\], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.
Detailed description
The primary objective of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 Curved Jaw and Generator G11 devices when used per the instructions for use.
Interventions
DEVICEENSEAL X1 Curved Jaw
ENSEAL X1 Curved Jaw is used for vessel transection 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
1. Primary laparoscopic or open procedure (upper gastrointestinal, lower gastrointestinal, or gynecological) where at least one vessel is planned to be transected by the ENSEAL X1 Curved Jaw device per the instructions for use; 2. Willingness to give consent and comply with all study-related evaluations and visit schedule; and 3. At least 18 years of age.
Exclusion criteria
1. Physical or psychological condition which would impair study participation; or 2. Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | On the day of transection (Day 0) | Number of vessels with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). |
| Number of Participants With Device-related Adverse Events (AEs) | From Day 0 up to post-procedure follow up visit (up to 28 days) | Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study devices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | On the day of transection (Day 0) | Number of participants with tissues bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues bundles by ENSEAL X1. |
| Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | On the day of transection (Day 0) | Number of participants with tissues grasping using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues grasping by ENSEAL X1. |
| Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | On the day of transection (Day 0) | Number of participants with tissues cutting using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues cutting by ENSEAL X1. |
| Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | On the day of transection (Day 0) | Number of participants with adhesion removal or division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1. |
| Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | On the day of transection (Day 0) | Number of vessels with hemostasis (Grade 1 to 4) based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). |
| Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures | On the day of transection (Day 0) | Percentage of Grade 4 vessel transections requiring hemostasis measures were planned to be reported. Data was not collected and analyzed for this outcome measure because there were no hemostatic grade 4 vessel transections. |
| Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | On the day of transection (Day 0) | Number of participants with tissues dissection using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues dissection by ENSEAL X1. |
| Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | On the day of transection (Day 0) | Number of participants with lymphatics bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatic bundles by ENSEAL X1. |
Countries
Italy, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ENSEAL X1 Curved Jaw All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal \[GI\], lower GI, or gynecological). | 145 |
| Total | 145 |
Baseline characteristics
| Characteristic | ENSEAL X1 Curved Jaw |
|---|---|
| Age, Continuous | 55.28 Years STANDARD_DEVIATION 15.904 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 133 Participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 145 |
| other Total, other adverse events | 58 / 145 |
| serious Total, serious adverse events | 10 / 145 |
Outcome results
Primary
Number of Participants With Device-related Adverse Events (AEs)
Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study devices.
Time frame: From Day 0 up to post-procedure follow up visit (up to 28 days)
Population: The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Participants With Device-related Adverse Events (AEs) | 2 Participants |
Primary
Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
Number of vessels with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Time frame: On the day of transection (Day 0)
Population: Full Analysis Set (FAS) included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | 279 Vessels transected |
Secondary
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Number of participants with adhesion removal or division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1.
Time frame: On the day of transection (Day 0)
Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Neither Satisfied or Dissatisfied | 1 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Satisfied | 27 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Satisfied | 21 Participants |
Secondary
Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Number of participants with lymphatics bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatic bundles by ENSEAL X1.
Time frame: On the day of transection (Day 0)
Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Neither Satisfied or Dissatisfied | 1 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Satisfied | 18 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Satisfied | 8 Participants |
Secondary
Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Number of participants with tissues bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues bundles by ENSEAL X1.
Time frame: On the day of transection (Day 0)
Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Neither Satisfied or Dissatisfied | 1 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Satisfied | 26 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Satisfied | 28 Participants |
Secondary
Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Number of participants with tissues cutting using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues cutting by ENSEAL X1.
Time frame: On the day of transection (Day 0)
Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Dissatisfied | 1 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Dissatisfied | 1 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Neither Satisfied or Dissatisfied | 3 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Satisfied | 38 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Satisfied | 44 Participants |
Secondary
Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Number of participants with tissues dissection using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues dissection by ENSEAL X1.
Time frame: On the day of transection (Day 0)
Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Neither Satisfied or Dissatisfied | 3 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Satisfied | 59 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Satisfied | 45 Participants |
Secondary
Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
Number of participants with tissues grasping using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues grasping by ENSEAL X1.
Time frame: On the day of transection (Day 0)
Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Dissatisfied | 0 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Dissatisfied | 4 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Neither Satisfied or Dissatisfied | 9 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Satisfied | 31 Participants |
| ENSEAL X1 Curved Jaw | Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Very Satisfied | 23 Participants |
Secondary
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale
Number of vessels with hemostasis (Grade 1 to 4) based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Time frame: On the day of transection (Day 0)
Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ENSEAL X1 Curved Jaw | Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | Grade 1 | 258 vessels transected |
| ENSEAL X1 Curved Jaw | Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | Grade 2 | 12 vessels transected |
| ENSEAL X1 Curved Jaw | Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | Grade 3 | 9 vessels transected |
| ENSEAL X1 Curved Jaw | Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | Grade 4 | 0 vessels transected |
Secondary
Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures
Percentage of Grade 4 vessel transections requiring hemostasis measures were planned to be reported. Data was not collected and analyzed for this outcome measure because there were no hemostatic grade 4 vessel transections.
Time frame: On the day of transection (Day 0)
Population: FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure.