Stapler Post-market Observational Study

November 5, 2020 updated by: Duomed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese patients eligible for laparoscopic Roux-en-Y gastric bypass surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events related to the index-procedure.
Time Frame: 1 month follow-up
Determination of postoperative anastomotic leaks and intraluminal/intraperitoneal bleeding.
1 month follow-up
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.
6 months follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duomed

Investigators

  • Principal Investigator: Hans Verhelst, Dr., ZOL, Genk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2017

Primary Completion (Actual)

September 16, 2020

Study Completion (Actual)

September 16, 2020

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 4, 2016

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ST-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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