Stapler Post-market Observational Study

Completed

• Conditions: Observational
• Interventions: Device: Endoscopic Linear Cutter Stapler and reloads

• Registration Number: NCT02922205
• Lead Sponsor: Duomed

Brief Summary

The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-04
• Study Start: 2017-04-06
• Primary Completion: 2020-09-16
• Study Completion: 2020-09-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-05
• Last Update Posted: 2020-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age at study entry is at least 18 years.
• Patient must sign and date the informed consent form prior to the index-procedure.
• Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
• Patient has a BMI ≥ 40 kg/m.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RYGB surgery	Endoscopic Linear Cutter Stapler and reloads	Obese patients eligible for laparoscopic Roux-en-Y gastric bypass (RYGB) surgery.

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events related to the index-procedure.	6 months follow-up	Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.

Secondary Outcome Measures

Name	Time	Method
Questionnaire on food tolerance.	1, 6, 12 and 24 month follow-up
Number of patients with bariatric surgery related re-interventions.	1, 6, 12 and 24 month follow-up
Percentage of excess weight loss.	1, 6, 12 and month follow-up	pre-operative weight (kg) minus postoperative weight (kg) divided by the ideal body weight (kg).
Number of adverse device effects.	1, 6, 12 and 24 month follow-up	Determination of staple line disruption.

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium