TrialGlobe

Clinical trial

A Post-market, Observational Registry With the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Bariatric Surgery

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04422236

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity, Roux-en-Y Gastric Bypass, Gastrectomy, Mini Gastric Bypass

Full registry criteria

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 proposed follow-up visits. * Patient has a contra-indication for laparoscopic bariatric surgery.

Treatments and study arms

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Device

Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.

Primary outcomes

To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.At index procedure

Conversion rate, number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.At discharge, up to 1 week

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.Follow-up 1: 3 weeks after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.Follow-up 2: 8 weeks after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.Follow-up 3: 6 months after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.Follow-up 4: 12 months after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.Follow-up 5: 18 months after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) in laparoscopic bariatric surgery.Follow-up 6: 24 months after the procedure

Number of re-interventions and number of participants with (serious) adverse events ≥ grade II Clavien-Dindo.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

AZ Delta vzw🇧🇪 Roeselare, Belgium
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