NCT04422236Active, not recruiting
A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
The purpose of this observational registry is to evaluate the safety and performance of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during laparoscopic bariatric surgery. The goal of the study will be achieved by assessing the device performance and by reporting of peri- and postoperative complications in a prospectively maintained database.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 25 May 2020
- Start date
- 28 Sept 2020
- Primary completion date
- 31 May 2025
- Lead sponsor
- Duomed
- Diseases
- Obesity
- NCT number
- NCT04422236
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 28 Sept 2020 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient has a contra-indication for laparoscopic bariatric surgery.
Other illness
- Patient has a history of bariatric surgery.
Other
- Patient is unable / unwilling to provide informed consent.
- Patient is unable to comply with the registry protocol or proposed follow-up visits.
Who the study is looking for
- Patient ≥ 18 years of age at registry entry.
- Patient and investigator signed and dated the informed consent form prior to the index-procedure.
- Patient has a BMI ≥ 35 kg/m2, with one or more related co-morbidities.
- Patient has a BMI ≥ 40 kg/m2.
- Patient is eligible for laparoscopic bariatric surgery.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Delta vzw Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.