Boom-IBD Clinical Trial

NCT05414955 | Completed DMC FDA Device

• 1 other identifier: Boom-IBD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 8

Brief Summary

Feasibility study of neuromodulation in patients with IBD.

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• Disease Activity Index

  CDAI (Crohn's Disease Activity Index Score) or MAYO Score (ulcerative colitis)

  up to 1 year

Study Arms (1)

Treated

EXPERIMENTAL

Patients implanted with neuromodulation

Device: Neuromodulation

Interventions

Neuromodulation DEVICE

Neuromodulation

Treated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• to 75 years of age
• Diagnosed with Crohn's Disease or ulcerative colitis
• Ability and willingness to consent to participate by signing the informed consent form
• Ability to comply with the protocol and willingness to comply with all follow-up requirements
• Still have part or all of their colon

You may not qualify if:

• Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
• Any psychiatric or personality disorder at the discretion of the study investigator
• Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
• Active clostridium difficile infection of the colon
• Active cytomegalovirus (CMV) infection of the colon
• Evidence of colonic perforation
• Fulminant colitis requiring emergency surgery
• Microscopic, ischemic or infectious colitis
• Unresected neoplasia of the colon
• Colonic stricture unable to pass a colonoscope
• History of cancer including melanoma (except for localized skin cancers) within 2 years
• Participation in another clinical trial within the past 30 days of device implant
• Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant
• Inability to operate the patient programmer

Sponsors & Collaborators

• Boomerang Medical: lead

Study Sites (8)

Phillip Fleshner, Inc.

Los Angeles, California, 90048, United States

Location

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

CU Anschutz

Aurora, Colorado, 80045, United States

Location

Kansas Gastroenterology

Wichita, Kansas, 67226-8119, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

University of Pennsylvania, Perelman School of Medicine Division of Colorectal Surgery

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: June 10, 2022
• Study Start: October 1, 2022
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)