Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03306966

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

Assessing the Safety and Performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy: a Monocentric Post-market Observational Study

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Duomed · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DEVICEEndoscopic 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.

Timeline

Start date
2018-05-01
Primary completion
2020-05-01
Completion
2021-01-30
First posted
2017-10-11
Last updated
2018-06-01

Source: ClinicalTrials.gov record NCT03306966. Inclusion in this directory is not an endorsement.