Obesity
Conditions
Brief summary
The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.
Detailed description
Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care.
Interventions
DEVICEAEON Endostapler
Surgery with AEON Endostapler
DEVICEEndo GIA Reloads with Tri-Staple Technology
Surgery with Endo GIA Reloads with Tri-Staple Technology
Sponsors
Lexington Medical Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing planned laparoscopic sleeve gastrectomy * Informed consent for study obtained and signed from each subject
Exclusion criteria
* Planned open surgical approach * Use of staple line reinforcement material (buttress) * Revision or other bariatric procedure * Patients with a bleeding disorder: known coagulopathy, or Platelets \<100,000, or Partial Thromboplastin Time (PTT) \>45sec, or Prothrombin Time (PT) \>15sec, or International Normalized Ratio (INR) \>1.5 * Patients with active HIV or Hepatitis B * Patients under the age of 18 on the date of the surgery * Patients who are pregnant * Patients using tobacco products within the last 2 weeks prior to surgery date * Patients using cortisone or related products within the last 2 weeks prior to surgery date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Endoscopic Staple Line Bleeding Score | Within surgery, after the last stapler firing | Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome. |
| Intraoperative Laparoscopic Staple Line Bleeding Score | Within surgery, images captured 10 seconds after the last stapler firing | Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Leakage Requiring Intervention | Within 30-day post-operative period | Number of participants with postoperative leakage requiring intervention |
| Number of Participants With Intraoperative or Postoperative Blood Transfusion | Within 72 hours of surgery start time | Number of participants with intraoperative or postoperative blood transfusion |
| Number of Participants With Reported Device-related Adverse Events | Within 30-day post-operative period | Number of participants with reported device-related adverse events |
| Number of Participants With Product Malfunction | Within surgery | Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AEON Endostapler Stapling performed with AEON Endostapler
AEON Endostapler: Surgery with AEON Endostapler | 30 |
| Endo GIA Reloads With Tri-Staple Technology Stapling performed with Endo GIA Reloads with Tri-Staple Technology
Endo GIA Reloads with Tri-Staple Technology: Surgery with Endo GIA Reloads with Tri-Staple Technology | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | AEON Endostapler | Endo GIA Reloads With Tri-Staple Technology | Total |
|---|---|---|---|
| Age, Continuous | 43.1 years STANDARD_DEVIATION 16 | 42.8 years STANDARD_DEVIATION 11.1 | 43.0 years STANDARD_DEVIATION 13.6 |
| BMI | 39.5 kg/m^2 STANDARD_DEVIATION 5.4 | 39.4 kg/m^2 STANDARD_DEVIATION 5.3 | 39.5 kg/m^2 STANDARD_DEVIATION 5.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 27 Participants | 52 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Intraoperative Endoscopic Staple Line Bleeding Score
Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.
Time frame: Within surgery, after the last stapler firing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AEON Endostapler | Intraoperative Endoscopic Staple Line Bleeding Score | 1.63 score on a scale | Standard Deviation 0.57 |
| Endo GIA Reloads With Tri-Staple Technology | Intraoperative Endoscopic Staple Line Bleeding Score | 2.00 score on a scale | Standard Deviation 0.55 |
Primary
Intraoperative Laparoscopic Staple Line Bleeding Score
Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.
Time frame: Within surgery, images captured 10 seconds after the last stapler firing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AEON Endostapler | Intraoperative Laparoscopic Staple Line Bleeding Score | 1.55 score on a scale | Standard Deviation 0.67 |
| Endo GIA Reloads With Tri-Staple Technology | Intraoperative Laparoscopic Staple Line Bleeding Score | 1.98 score on a scale | Standard Deviation 0.74 |
Secondary
Number of Participants With Intraoperative or Postoperative Blood Transfusion
Number of participants with intraoperative or postoperative blood transfusion
Time frame: Within 72 hours of surgery start time
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AEON Endostapler | Number of Participants With Intraoperative or Postoperative Blood Transfusion | 0 Participants |
| Endo GIA Reloads With Tri-Staple Technology | Number of Participants With Intraoperative or Postoperative Blood Transfusion | 0 Participants |
Secondary
Number of Participants With Postoperative Leakage Requiring Intervention
Number of participants with postoperative leakage requiring intervention
Time frame: Within 30-day post-operative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AEON Endostapler | Number of Participants With Postoperative Leakage Requiring Intervention | 0 Participants |
| Endo GIA Reloads With Tri-Staple Technology | Number of Participants With Postoperative Leakage Requiring Intervention | 0 Participants |
Secondary
Number of Participants With Product Malfunction
Number of participants with product malfunction. Product malfunction means any occurrence during the surgery where the stapler does not perform as intended.
Time frame: Within surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AEON Endostapler | Number of Participants With Product Malfunction | 0 Participants |
| Endo GIA Reloads With Tri-Staple Technology | Number of Participants With Product Malfunction | 0 Participants |
Secondary
Number of Participants With Reported Device-related Adverse Events
Number of participants with reported device-related adverse events
Time frame: Within 30-day post-operative period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AEON Endostapler | Number of Participants With Reported Device-related Adverse Events | 0 Participants |
| Endo GIA Reloads With Tri-Staple Technology | Number of Participants With Reported Device-related Adverse Events | 0 Participants |