Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.

Duomed1 site in 1 country100 target enrollmentApril 6, 2017

ConditionsObservational

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Observational
Sponsor: Duomed
Enrollment: 100
Locations: 1
Primary Endpoint: Number of patients with adverse events related to the index-procedure.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 6, 2017

End Date

September 16, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Duomed

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of patients with adverse events related to the index-procedure.

Time Frame: 6 months follow-up

Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.

Secondary Outcomes

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)
Number of adverse device effects.(1, 6, 12 and 24 month follow-up)