NCT04808206Active, not recruiting
A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
A Multicentric Prospective Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy
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 the clinical efficacy of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical). The goal of the study will be achieved by reporting peri- and postoperative complications and the clinical outcome after surgery in a prospectively maintained database.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 11 Mar 2021
- Start date
- 1 Jun 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Duomed
- Diseases
- Obesity
- NCT number
- NCT04808206
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Jun 2022 to the primary completion date, 31 Dec 2025
- 3 sites 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 the 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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Oost-Limburg, Campus St.-Jan Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| Hôpital de Nivelles, groupe Jolimont Coordinator of this site? Confirm its status | Haine-Saint-Paul | Belgium | Unknown status |
| Ziekenhuis Maas en Kempen Coordinator of this site? Confirm its status | Maaseik | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.