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Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy

NCT03306966 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-06-01

No results posted yet for this study

Summary

The purpose of this observational study is to evaluate the safety and performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the ascending colon. 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

Interventions

DEVICE

Endoscopic Linear Cutter Stapler and Reloads (Frankenman)

The Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman received CE-mark in April 2013. It is used to staple and simultaneously divide tissue from the central line.

Sponsors & Collaborators

  • Duomed

    lead INDUSTRY

Principal Investigators

  • Kurt Van Der Speeten, Dr · ZOL, Genk

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-05-01
Completion
2021-01-30

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Diseases

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 NCT03306966 on ClinicalTrials.gov