Status:
COMPLETED
Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
Lead Sponsor:
Mercy Medical Center
Conditions:
Colonic Polyp
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This is a prospective, post-market, randomized clinical trial comparing colonic ESD procedures utilizing the DiLumen™ Endolumenal Interventional Platform to colonic ESD procedures that are performed w...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2020
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT03846609
Start Date
February 19 2019
End Date
December 10 2020
Last Update
December 11 2020
Active Locations (1)
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1
Mercy Medical Center
Baltimore, Maryland, United States, 21202