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Stapler Post-market Observational Study

NCT02922205 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-11-06

No results posted yet for this study

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.

Conditions

  • Observational

Interventions

DEVICE

Endoscopic Linear Cutter Stapler and reloads

Endoscopic Linear Cutter Stapler and reloads

Sponsors & Collaborators

  • Duomed

    lead INDUSTRY

Principal Investigators

  • Hans Verhelst, Dr. · ZOL, Genk

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2020-09-16
Completion
2020-09-16

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02922205 on ClinicalTrials.gov