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

NCT04422236 | Active Not Recruiting

• 1 other identifier: DM-Delta-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

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

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

  At index procedure

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

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

  At discharge, up to 1 week

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

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

  Follow-up 1: 3 weeks after the procedure

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

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

  Follow-up 2: 8 weeks after the procedure

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

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

  Follow-up 3: 6 months after the procedure

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

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

  Follow-up 4: 12 months after the procedure

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

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

  Follow-up 5: 18 months after the procedure

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

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

  Follow-up 6: 24 months after the procedure

Secondary Outcomes (10)

• Device performance

  At index procedure

• Device performance

  At index procedure

• Clinical efficacy

  Follow-up 1: 3 weeks after the procedure

• Clinical efficacy

  Follow-up 2: 8 weeks after the procedure

• Clinical efficacy

  Follow-up 3: 6 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 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
• Healthy Volunteers: No
• 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 200 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 proposed follow-up visits.
• Patient has a contra-indication for laparoscopic bariatric surgery.

Sponsors & Collaborators

• Duomed: lead

Study Sites (1)

AZ Delta vzw

Roeselare, 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

• Bart Smet, Dr.

  AZ Delta vzw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 9, 2020
• Study Start: September 28, 2020
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)