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

Obesity Clinical Trial

— STAP-Delta  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04422236
• Other study ID #: DM-Delta-01
• Status: Active, not recruiting
• Start date: September 28, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2023
• Source: Duomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: May 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Belgium	AZ Delta vzw	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
Duomed

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Device performance	Assessment of device performance (e.g. sharpness of the blade, staple-line formation, etc.).	At index procedure
Secondary	Clinical efficacy	Weight loss	Follow-up 1: 3 weeks after the procedure
Secondary	Clinical efficacy	Weight loss	Follow-up 2: 8 weeks after the procedure
Secondary	Clinical efficacy	Weight loss	Follow-up 3: 6 months after the procedure
Secondary	Clinical efficacy	Weight loss	Follow-up 4: 12 months after the procedure
Secondary	Clinical efficacy	Weight loss	Follow-up 5: 18 months after the procedure
Secondary	Clinical efficacy	Weight loss	Follow-up 6: 24 months after the procedure
Secondary	Clinical efficacy	Comorbidity	Follow-up 4: 12 months after the procedure
Secondary	Clinical efficacy	Comorbidity	Follow-up 6: 24 months after the procedure