Effectiveness and Safety of the Endoscopic Removal of Large and Flat Colonic Polyps With LumenR RetractorTM

Completed · Not applicable

Conditions studied: Colonic Adenomatous Polyps

In brief

Colorectal cancer accounted for 142,570 new cancer cases and 51,370 cancer deaths in USA in 2010 and worldwide has become the third most common cancer and second leading cause of cancer related deaths. Colonic adenomatous polyps are known precursors of colorectal cancer and endoscopic removal of the polyps prevents development of colon cancer. Removal of such large polyps requires special endoscopic techniques-endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), which are more technically difficult to perform, labor intensive, time consuming and carries higher risks of complications (bleeding, perforations, etc.). The purpose of this study is to determine the effectiveness and safety of the LumenR Retractor in performing EMR and ESD. It is hypothesized that the use of this modified colonic overtube will simplify colonoscopic removal of difficult polyps, decrease the time needed to complete the procedure and decrease the rate of complications post endoscopic removal of large and flat colonic.

Key facts

Study ID

NCT02051465

Run by

Mercy Medical Center

People needed

60

Starts

2013-05-01

Expected to finish

2017-12-01

Last updated by the study team

2018-08-21

Who can join

Age: 17 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Colonic polyps 2cm in size or greater
• Subject 17 to 90 years of age
• Female subjects must have negative pregnancy test within last 24 hours timeline, and no intentions to become pregnant or be sterilized during participation in study.

You may not qualify if…

• Colonic polyps less than 2cm in size
• Under 17 or over 90 years of age
• Unwilling to consent or comply with protocol requirements
• Uncorrectable bleeding disorders (INR more than 1.5; platlet count less than 50,000)
• Allergy to materials from which the device is constructed- Polyvinyl Chloride, Nitinol, Watershed, Polycarbonate, and Polytetrafluoroethylene
• Received experimental drug or device within 3 months prior to start of study
• Treatment with an investigational drug or medical device during the study period
• Female subjects that are pregnant or lactating or intending to become pregnant during the period of the study, or who would not use an adequate method of contraception (contraceptive pill, intra-uterine device) for the duration of the study
• Psychological condition, or under treatment for any condition which, in the opinion of the Investigator and/or consulting physician(s), would constitute an unwarranted risk

Where it is running

• Mercy Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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