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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Colon Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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