Assessing the Safety and Performance of the easyEndoTM Universal Linear Cutting Stapler in Laparoscopic Gastric Bypass Surgery

NCT03968757 | Completed

• 1 other identifier: STAP-D
• Study Type: observational
• Target: 150
• 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 used in laparoscopic RYGB surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.

Conditions

Roux-en-Y Gastric Bypass; Obesity

Outcome Measures

Primary Outcomes (6)

• To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

  Number of participants with peri-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  at index-procedure

• To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

  Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  at discharge, up to 1 week

• To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

  Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  at 6 weeks follow-up

• To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

  Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  at 6 months follow-up

• To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

  Number of participants with postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  at 12 months follow-up

• To evaluate the safety of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

  Number of participants with post-operative anastomotic leaks and intraluminal/intraperitoneal bleeding.

  at 24 months follow-up

Secondary Outcomes (17)

• To evaluate the performance of the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)

  at index-procedure

• To evaluate the performance of the easyEndoTM Universal Linear Cutting

  at index-procedure

• To evaluate the efficacy of the laparoscopic RYGB surgery

  at index-procedure

• To evaluate the efficacy of the laparoscopic RYGB surgery

  at discharge, up to 1 week

• To evaluate the efficacy of the laparoscopic RYGB surgery

  at 6 weeks follow-up

Study Arms (1)

Obese patients eligible for laparoscopic RYGB surgery.

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

Interventions

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

Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.

Obese patients eligible for laparoscopic RYGB 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 RYGB surgery. This registry will collect data from 150 laparoscopic RYGB procedures in which anastomoses are created with the easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical).

You may qualify if:

• Age at study entry is at least 18 years.
• Patient must sign and date the informed consent form prior to the index-procedure. If the patient is not able to give informed consent, a legally authorized representative must give informed consent on his/her behalf.
• Patient has a BMI ≥ 35 kg/m2 with one of more related co-morbidities.
• Patient has a BMI ≥ 40 kg/m2.

You may not qualify if:

• Patient is pregnant.
• History of bariatric surgery.
• Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).

Sponsors & Collaborators

• Duomed: lead

Study Sites (1)

AZ Sint-Jan Brugge

Bruges, West Flanders, 8000, 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 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 22, 2019
• First Posted: May 30, 2019
• Study Start: July 4, 2019
• Primary Completion: April 25, 2023
• Study Completion: June 7, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)