Evaluation of a Double Balloon Interventional Platform (DiLumen) for Complex Colonic ESD

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Study Evaluating the Performance of a Double Balloon Interventional Platform (DiLumen) for Facilitating Complex Colonic ESD

Conditions
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Colonic Polyp

Intervention / Treatment
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* Device: double balloon interventional platform (DiLumen)
* Device: no double balloon interventional platform (DiLumen)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)]
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: double balloon platform<br>Device: double balloon interventional platform (DiLumen) | Device: double balloon interventional platform (DiLumen)<br>* double balloon interventional platform (DiLumen) is used for removal of colonic polyp<br>|
| Active Comparator: no double balloon platform<br>Device: no double balloon interventional platform (DiLumen) | Device: no double balloon interventional platform (DiLumen)<br>* double balloon interventional platform (DiLumen) is not used for removal of colonic polyp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total case time | Time from the beginning of procedure until the end of the entire procedure Iin minutes) | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navigation time | Time from endoscope insertion into patient's rectum till colonic lesion is reached (in minutes) | 3-month | 
| Dissection time | Time from the start of lesion removal till the lesion removal is completed (in minutes) | 3-month | 
| Length of Hospital Stay | Days of admission to the hospital post procedure till the patient is discharged from the hospital (in days) | 3-month | 
| Cost of service | Total financial cost (in USA dollars) of the medical care received pertaining to the procedure and related follow-up | 3-month | 
| 30-day readmittance rate | Number of patients readmitted to the hospital during first 30 days post colonoscopy | 30-day | 
| Patient satisfaction survey | Patients are given three statements regarding their procedures for which they answer if they agree or disagree with the statement. | 3-month | 
| Histologic pathology summary | The final pathological determination of the excised specimen, as determined by pathological examination | 3-month | 
| Rate of complications | Adverse effects that occur during the study | 3-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic Submucosal Dissection