Obesity
Conditions
Brief summary
The goal of this prospective, post-market study is to evaluate safety and efficacy of the AEON™ Endostapler when used in laparoscopic Roux-en-Y gastric bypass surgery.
Detailed description
Stapler performance will be evaluated by incidence and degree of staple line bleeding from endoscopic and laparoscopic images, evaluated by a third-party. The study will include 25 total consecutive cases of individuals undergoing a planned laparoscopic Roux-en-Y gastric bypass (GB). The GB 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
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 Roux-en-Y gastric bypass * 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 PTT \> 45sec, or PT\> 15sec, or 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 |
|---|---|
| Incidence of reported device-related adverse events | Within 30-day post-operative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic staple line bleeding | Within surgery | Incidence of intraoperative staple line bleeding from endoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Endoscope Images (1: No bleeding, 5: Profuse Bleeding) |
| Laparoscopic staple line bleeding | Within surgery | Incidence of intraoperative staple line bleeding from laparoscopic images as measured by the provided bleeding severity scale - Bleeding Severity Scale for Laparoscope Images (1: No bleeding, 5: Profuse Bleeding) |
| Incidence of intraoperative or postoperative blood transfusion | Within 72 hours of surgery start time | — |
| Incidence of product malfunction | Within surgery | — |
Countries
United States
Outcome results
None listed