WithdrawnNo phase
Endostapler Gastric Bypass Study
Key facts
- Who runs it
- Lexington Medical Inc.
- Where
- Holyoke, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Started
- 18 Jan 2021
- Ended
- Dec 2023
- Type of study
- Observational
- Treatments tested
- AEON Endostapler
- Record updated
- 4 October 2023
- Why it stopped
- voluntarily withdrawn
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Patients undergoing planned laparoscopic Roux-en-Y gastric bypass
- Informed consent for study obtained and signed from each subject
Who cannot take part
- Planned open surgical approach
- 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
- Patients with active HIV or Hepatitis B
- Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or PTT > 45sec, or PT> 15sec, or INR>1.5
- Patients under the age of 18 on the date of the surgery
- Use of staple line reinforcement material (buttress)
- Revision or other bariatric procedure
- Patients who are pregnant
Where in United States
- Holyoke Medical CenterHolyoke, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- AEON Endostapler
Stapling performed with AEON Endostapler
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety and Efficacy of the AEON™ Endostapler in Laparoscopic Roux-en-Y Gastric Bypass Surgery
- Record updated
- 4 October 2023