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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Gastrectomy; Roux-en-Y Gastric Bypass; Mini Gastric Bypass
• Intervention / Treatment: Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

• Study Contact: Name: Bart Smet, Dr.; Phone Number: +32 (0)51 23 71 09; Email: bart.smet@azdelta.be

Study Locations

• Belgium
  • Roeselare, Belgium
    • AZ Delta VZW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese patients eligible for laparoscopic bariatric surgery	Device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical); Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device performance	Number of procedures with technical success defined as bariatric surgery as intended, without technical difficulties and without conversion to open laparotomy.	At index procedure
Device performance	Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).	At index procedure
Clinical efficacy	Weight loss	Follow-up 1: 3 weeks after the procedure
Clinical efficacy	Weight loss	Follow-up 2: 8 weeks after the procedure
Clinical efficacy	Weight loss	Follow-up 3: 6 months after the procedure
Clinical efficacy	Weight loss	Follow-up 4: 12 months after the procedure
Clinical efficacy	Weight loss	Follow-up 5: 18 months after the procedure
Clinical efficacy	Weight loss	Follow-up 6: 24 months after the procedure
Clinical efficacy	Comorbidity	Follow-up 4: 12 months after the procedure
Clinical efficacy	Comorbidity	Follow-up 6: 24 months after the procedure

Collaborators and Investigators

• Sponsor: Duomed
• Investigators: Principal Investigator: Bart Smet, Dr., AZ Delta VZW

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DM-Delta-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No