Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
Completed · Not applicable
Conditions studied: Colonic Polyp
In brief
The purpose of this randomized study is to compare ESD procedural time and cost facilitated with a dual balloon accessory device versus ESD procedures performed without the accessory device. Study is designed to detect if the double balloon interventional platform helps to perform removal of benign complex colonic lesions safer and in more efficient way.
Key facts
- Study ID
- NCT03846609
- Run by
- Mercy Medical Center
- People needed
- 147
- Starts
- 2019-02-19
- Expected to finish
- 2020-12-10
- Last updated by the study team
- 2020-12-11
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women 18-85 years of age.
- Have ability to understand the requirements of the study and provide written informed consent
- Suspected complex adenomatous polyps in the large intestine defined as sessile or polypoid lesions 2 cm and larger in size.
- No medical contraindication to endoscopic submucosal dissection (ESD).
You may not qualify if…
- Contraindication to colonoscopy, such as active colitis, diverticulitis, perforation, or stricture.
- History of open or laparoscopic colorectal surgery.
- History of Inflammatory Bowel Disease (IBD).
- Any medical or surgical condition that would preclude the endoscopic removal of the polyp.
- Anatomy or other factors that prohibit safe access to the large intestine such as previous radiation therapy to the affected area, known colonic strictures, extensive colonic diverticuli, etc.
- History of AIDS, HIV, or active hepatitis.
- History of mental illness, including psychological or neurological conditions (addiction to substances such as alcohol. e.g.) that in the investigator's opinion would pre-empt their ability or willingness to participate in the study.
- Patients who are pregnant or lactating.
- Currently involved in another investigational product for similar purposes.
Where it is running
- Mercy Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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