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

Last updated: March 27, 2025
Sponsor: Duomed
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Prevention

Obesity

Weight Loss

Treatment

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

Clinical Study ID

NCT04808206
DM-PRO-ST2021
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient ≥ 18 years of age at registry entry

  • Patient and investigator signed and dated the informed consent form prior to theindex-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

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-upvisits.

  • Patient has a contra-indication for laparoscopic bariatric surgery.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Europa Ziekenhuizen, campus St.-Michiel

    Etterbeek,
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg, campus St.-Jan

    Genk,
    Belgium

    Site Not Available

  • Hôpital de Nivelles, groupe Jolimont

    Haine-Saint-Paul,
    Belgium

    Site Not Available

  • Ziekenhuis Maas en Kempen

    Maaseik,
    Belgium

    Site Not Available

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