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

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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyp
• Intervention / Treatment: Device: double balloon interventional platform (DiLumen); Device: no double balloon interventional platform (DiLumen)

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 Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: double balloon platform; Device: double balloon interventional platform (DiLumen)	Device: double balloon interventional platform (DiLumen); double balloon interventional platform (DiLumen) is used for removal of colonic polyp
Active Comparator: no double balloon platform; Device: no double balloon interventional platform (DiLumen)	Device: no double balloon interventional platform (DiLumen); double balloon interventional platform (DiLumen) is not used for removal of colonic polyp

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mercy Medical Center
• Investigators: Principal Investigator: Sergey V Kantsevoy, MD, PhD, Director of The Therapeutic Endoscopy Mercy Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2019
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): December 10, 2020

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Endoscopic Submucosal Dissection
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: 1368768-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study records should be stored in a secure area to limit access to study personnel and maintain confidentiality of the records.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes