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

Not Applicable

Completed

• Conditions: Colonic Polyp
• Interventions: Device: double balloon interventional platform (DiLumen); Device: no double balloon interventional platform (DiLumen)

• Registration Number: NCT03846609
• Lead Sponsor: Mercy Medical Center

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.

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-18
• Study Start: 2019-02-19
• Study First Posted: 2019-02-19
• Primary Completion: 2020-03-15
• Status Verified: 2020-12
• Study Completion: 2020-12-10
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
double balloon platform	double balloon interventional platform (DiLumen)	Device: double balloon interventional platform (DiLumen)
no double balloon platform	no double balloon interventional platform (DiLumen)	Device: no double balloon interventional platform (DiLumen)

Primary Outcome Measures

Name	Time	Method
Total case time	3-month	Time from the beginning of procedure until the end of the entire procedure Iin minutes)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States