Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
NCT ID: NCT03846609
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
147 participants
INTERVENTIONAL
2019-02-19
2020-12-10
Brief Summary
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Detailed Description
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The study participants will be randomly assigned to study group and control group The treatment group will consist of up to 100 subjects treated with the DiLumen™ device. The control group will consist of up to 100 subjects treated without DiLumen™ device. Assessments will include procedure timepoints, anesthesia use, polyp location and classification, over-all cost assessment, and general complications.
The primary outcome will be analyzed using parametric statistics to compare the means of the study and control groups. P-values and confidence intervals will be reported. Descriptive and summary statistics will also be employed. Secondary outcomes will be summarized with descriptive statistics.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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double balloon platform
Device: double balloon interventional platform (DiLumen)
double balloon interventional platform (DiLumen)
double balloon interventional platform (DiLumen) is used for removal of colonic polyp
no double balloon platform
Device: no double balloon interventional platform (DiLumen)
no double balloon interventional platform (DiLumen)
double balloon interventional platform (DiLumen) is not used for removal of colonic polyp
Interventions
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double balloon interventional platform (DiLumen)
double balloon interventional platform (DiLumen) is used for removal of colonic polyp
no double balloon interventional platform (DiLumen)
double balloon interventional platform (DiLumen) is not used for removal of colonic polyp
Eligibility Criteria
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Inclusion Criteria
2. Have ability to understand the requirements of the study and provide written informed consent
3. Suspected complex adenomatous polyps in the large intestine defined as sessile or polypoid lesions 2 cm and larger in size.
4. No medical contraindication to endoscopic submucosal dissection (ESD).
Exclusion Criteria
2. History of open or laparoscopic colorectal surgery.
3. History of Inflammatory Bowel Disease (IBD).
4. Any medical or surgical condition that would preclude the endoscopic removal of the polyp.
5. 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.
6. History of AIDS, HIV, or active hepatitis.
7. 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.
8. Patients who are pregnant or lactating.
9. Currently involved in another investigational product for similar purposes.
18 Years
85 Years
ALL
No
Sponsors
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Mercy Medical Center
OTHER
Responsible Party
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Sergey Kantsevoy, M.D., Ph.D.
Director of Therapeutic Endoscopy
Principal Investigators
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Sergey V Kantsevoy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Director of The Therapeutic Endoscopy Mercy Medical Center
Locations
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Mercy Medical Center
Baltimore, Maryland, United States
Countries
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References
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Kantsevoy SV, Palmer A, Hockett D, Vilches A. Prospective, randomized controlled study evaluating a double-balloon interventional endoscopic platform for colorectal endoscopic submucosal dissection (with video). Gastrointest Endosc. 2025 Jan;101(1):149-157. doi: 10.1016/j.gie.2024.07.001. Epub 2024 Jul 5.
Other Identifiers
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1368768-2
Identifier Type: -
Identifier Source: org_study_id