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

Duomed

Status: Withdrawn

Conditions: Colon Cancer

Treatments: Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)

Study type: Observational

Funder types: Industry

Identifiers

NCT03306966

ST-02

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Colon cancer patients

Description:

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

Treatment:

Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)