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

NCT04808206 | Active Not Recruiting

• 1 other identifier: DM-PRO-ST2021
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Obesity; Roux-en-Y Gastric Bypass; Gastrostomy; Nissen Sleeve

Outcome Measures

Primary Outcomes (6)

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

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

  At index procedure

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

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

  At discharge up to 1 week

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

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

  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)

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

  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)

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

  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)

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

  Follow-up 4: 24 months after the procedure

Secondary Outcomes (8)

• Device performance

  At index procedure

• Device performance

  At index procedure

• Clinical efficacy - weight loss

  Follow-up 1: 1 month after the procedure

• Clinical efficacy - weight loss

  Follow-up 2: 6 months after the procedure

• Clinical efficacy - weight loss

  Follow-up 3: 12 months after the procedure

Study Arms (1)

Obese patients eligible for laparoscopic bariatric surgery

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

Interventions

easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical) DEVICE

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

Obese patients eligible for laparoscopic bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients eligible for laparoscopic bariatric surgery. This registry will collect data from 250 laparoscopic bariatric procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duomed: lead

Study Sites (3)

Ziekenhuis Oost-Limburg, campus St.-Jan

Genk, Belgium

Location

Hôpital de Nivelles, groupe Jolimont

Haine-Saint-Paul, Belgium

Location

Ziekenhuis Maas en Kempen

Maaseik, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salvatore Lobue, MD

  Hôpital de Nivelles (groupe Jolimont), Haine-Saint-Paul, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 22, 2021
• Study Start: June 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3)