Active — Not RecruitingNot Applicable

A Registry of Laparoscopic Bariatric Surgery Using Stapling Devices: Observation of Safety and Clinical Efficacy

Belgium150 participantsStarted 2022-06-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Patient is unable/unwilling to provide informed consent. * Patient has a history of bariatric surgery. * Patient is unable to comply with the registry protocol or the proposed follow-up visits. * Patient has a contra-indication for laparoscopic bariatric surgery.

What they're measuring

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: At index procedure

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: At discharge up to 1 week

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: Follow-up 1: 1 month after the procedure

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: Follow-up 2: 6 months after the procedure

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: Follow-up 3: 12 months after the procedure

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: Follow-up 4: 24 months after the procedure

Trial details

NCT IDNCT04808206

SponsorDuomed

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Obesity trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: At index procedure

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: At discharge up to 1 week

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: Follow-up 1: 1 month after the procedure

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: Follow-up 2: 6 months after the procedure

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: Follow-up 3: 12 months after the procedure

Safety of laparoscopic bariatric surgery using stapling devices (easyEndoTM Universal Linear Cutting Stapler and reloads - Ezisurg Medical)

Timeframe: Follow-up 4: 24 months after the procedure