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A Post-market Observational Study With the easyEndoTM Universal Linear Cutting Stapler in Standard Laparoscopic and Robot-assisted Laparoscopic Roux-en-Y Gastric Bypass (RYGB) Surgery

NCT04543526 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-01-11

No results posted yet for this study

Summary

The primary purpose of this observational registry is to evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads from Ezisurg Medical when used to create anastomoses during standard and robot-assisted laparoscopic Roux-en-Y Gastric Bypass (RYGB) surgery. Stapler performance during surgery as well as post-operative pain and the clinical efficacy of the procedures will be determined as secondary objectives.

Conditions

Interventions

DEVICE

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creating anastomoses during standard and robot-assisted laparoscopic RYGB, manufactured by Ezisurg Medical.

Sponsors & Collaborators

  • Duomed

    lead INDUSTRY

Principal Investigators

  • Hans Verhelst, Dr. · Ziekenhuis Oost-Limburg (ZOL)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-10-31
Completion
2024-11-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04543526 on ClinicalTrials.gov