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

Duomed0 sitesMay 1, 2018

ConditionsColon Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Colon Cancer
Sponsor: Duomed
Primary Endpoint: Number of patients with adverse events related to the index-procedure.
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 1, 2018

End Date

January 30, 2021

Last Updated

7 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 tumor in the ascending colon.

Exclusion Criteria

•Patient is pregnant.
•Patient has inflammatory bowel disease (ulcerative colitis, Crohn's disease).
•Patient has symptomatic diverticulitis.
•Patient has bowel trauma.
•Patient has peritoneal carcinomatosis.
•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 peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.

Secondary Outcomes

Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.(6 months follow-up)
Number of adverse device effects.(6 months follow-up)
Number of patients with colectomy related re-interventions.(6 months follow-up)