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

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.

Study Overview

• Status: Withdrawn
• Conditions: Colon Cancer
• Intervention / Treatment: Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.

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 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colon cancer patients; Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.	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.

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.	Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.	3 to 4 weeks follow-up
Number of patients with adverse events related to the index-procedure.	Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.	3 months follow-up
Number of patients with adverse events related to the index-procedure.	Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.	6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse device effects.	Determination of the sharpness of the blade and occurrence of disruption of the staple line.	3 to 4 weeks follow-up
Number of adverse device effects.	Determination of the sharpness of the blade and occurrence of disruption of the staple line.	3 months follow-up
Number of adverse device effects.	Determination of the sharpness of the blade and occurrence of disruption of the staple line.	6 months follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.		3 to 4 weeks follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.		3 months follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.		6 months follow-up
Number of patients with colectomy related re-interventions.		3 to 4 weeks follow-up
Number of patients with colectomy related re-interventions.		3 months follow-up
Number of patients with colectomy related re-interventions.		6 months follow-up

Collaborators and Investigators

• Sponsor: Duomed
• Investigators: Principal Investigator: Kurt Van Der Speeten, Dr, ZOL, Genk

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): January 30, 2021

Study Registration Dates

• First Submitted: October 6, 2017
• First Submitted That Met QC Criteria: October 6, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Ascending colon
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: ST-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No