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

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846609
• Other study ID #: 1368768-2
• Status: Completed
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: December 10, 2020

Study information

• Verified date: December 2020
• Source: Mercy Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 10, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total case time	Time from the beginning of procedure until the end of the entire procedure Iin minutes)	3-month
Secondary	Navigation time	Time from endoscope insertion into patient's rectum till colonic lesion is reached (in minutes)	3-month
Secondary	Dissection time	Time from the start of lesion removal till the lesion removal is completed (in minutes)	3-month
Secondary	Length of Hospital Stay	Days of admission to the hospital post procedure till the patient is discharged from the hospital (in days)	3-month
Secondary	Cost of service	Total financial cost (in USA dollars) of the medical care received pertaining to the procedure and related follow-up	3-month
Secondary	30-day readmittance rate	Number of patients readmitted to the hospital during first 30 days post colonoscopy	30-day
Secondary	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
Secondary	Histologic pathology summary	The final pathological determination of the excised specimen, as determined by pathological examination	3-month
Secondary	Rate of complications	Adverse effects that occur during the study	3-month