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

D

Duomed

Status

Active, not recruiting

Conditions

Obesity
Mini Gastric Bypass
Gastrectomy
Roux-en-Y Gastric Bypass

Treatments

Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Study type

Observational

Funder types

Industry

Identifiers

NCT04422236
DM-Delta-01

Details and patient eligibility

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Obese patients eligible for laparoscopic bariatric surgery
Treatment:
Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems