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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04712526
Other study ID # Endostapler03
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 18, 2021
Est. completion date December 2023

Study information

Verified date October 2023
Source Lexington Medical Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AEON Endostapler
Surgery with AEON Endostapler

Locations

Country Name City State
United States Holyoke Medical Center Holyoke Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Lexington Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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