Obesity Clinical Trial
Official title:
Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery
Verified date | October 2023 |
Source | Lexington Medical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2023 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Holyoke Medical Center | Holyoke | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Lexington Medical Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of reported device-related adverse events | Within 30-day post-operative period | ||
Secondary | Endoscopic staple line bleeding | 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) | Within surgery | |
Secondary | Laparoscopic staple line bleeding | 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) | Within surgery | |
Secondary | Incidence of intraoperative or postoperative blood transfusion | Within 72 hours of surgery start time | ||
Secondary | Incidence of product malfunction | Within surgery |
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