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

NCT03846609 | Completed DMC FDA Device

• 1 other identifier: 1368768-2
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyp

Keywords

Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• Total case time

  Time from the beginning of procedure until the end of the entire procedure Iin minutes)

  3-month

Secondary Outcomes (8)

• Navigation time

  3-month

• Dissection time

  3-month

• Length of Hospital Stay

  3-month

• Cost of service

  3-month

• 30-day readmittance rate

  30-day

Study Arms (2)

double balloon platform

EXPERIMENTAL

Device: double balloon interventional platform (DiLumen)

Device: double balloon interventional platform (DiLumen)

no double balloon platform

ACTIVE COMPARATOR

Device: no double balloon interventional platform (DiLumen)

Device: no double balloon interventional platform (DiLumen)

Interventions

double balloon interventional platform (DiLumen) DEVICE

double balloon interventional platform (DiLumen) is used for removal of colonic polyp

double balloon platform

no double balloon interventional platform (DiLumen) DEVICE

double balloon interventional platform (DiLumen) is not used for removal of colonic polyp

no double balloon platform

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mercy Medical Center: lead

Study Sites (1)

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

• Kantsevoy SV, Palmer A, Hockett D, Vilches A. Prospective, randomized controlled study evaluating a double-balloon interventional endoscopic platform for colorectal endoscopic submucosal dissection (with video). Gastrointest Endosc. 2025 Jan;101(1):149-157. doi: 10.1016/j.gie.2024.07.001. Epub 2024 Jul 5.

  PMID: 38971202 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sergey V Kantsevoy, MD, PhD

  Director of The Therapeutic Endoscopy Mercy Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be randomly assigned to study or control group. The patients will not know their assignment until completion of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Therapeutic Endoscopy

Model Details: The patients will be assigned into study group \[procedure performed with use of double balloon interventional platform (DiLumen)\] or control group \[procedure done without the use of double balloon interventional platform (DiLumen)\]

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 19, 2019
• Study Start: February 19, 2019
• Primary Completion: March 15, 2020
• Study Completion: December 10, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)