Clinical trial NCT03846609: Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD
Official title: A Randomized Controlled Study Evaluating the Performance of a Double Balloon Interventional Platform (DiLumen) for Facilitating Complex Colonic ESD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Keywords: Endoscopic Submucosal Dissection
Lead sponsor: Mercy Medical Center
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be assigned into study group \[procedure performed with use of double balloon interventional platform (DiLumen)\] or control group \[procedure done without the use of double balloon interventional platform (DiLumen)\]
Primary purpose: TREATMENT

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 designed to detect if the double balloon interventional platform helps to perform removal of benign complex colonic lesions safer and in more efficient way.

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 without use the DiLumen™ device.

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.

Eligibility criteria: Inclusion Criteria:

1. Men or women 18-85 years of age.
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:

1. Contraindication to colonoscopy, such as active colitis, diverticulitis, perforation, or stricture.
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.

Primary outcomes:
measure: Total case time
timeFrame: 3-month
Secondary outcomes:
measure: Navigation time
timeFrame: 3-month
measure: Dissection time
timeFrame: 3-month
measure: Length of Hospital Stay
timeFrame: 3-month
measure: Cost of service
timeFrame: 3-month
measure: 30-day readmittance rate
timeFrame: 30-day
measure: Patient satisfaction survey
timeFrame: 3-month
measure: Histologic pathology summary
timeFrame: 3-month
measure: Rate of complications
timeFrame: 3-month
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
Study officials:
affiliation: Director of The Therapeutic Endoscopy Mercy Medical Center
name: Sergey V Kantsevoy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: