WithdrawnNot Applicable

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

Stopped: Design modification

0Started 2018-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of patients with adverse events related to the index-procedure.

Timeframe: 3 to 4 weeks follow-up

Number of patients with adverse events related to the index-procedure.

Timeframe: 3 months follow-up

Number of patients with adverse events related to the index-procedure.

Timeframe: 6 months follow-up

Trial details

NCT IDNCT03306966

SponsorDuomed

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-05-01

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