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NCT05414955 Clinical Trial

Boom-IBD Clinical Trial

IBD Clinical Trial

Official title:
Boom-IBD Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05414955
Other study ID # Boom-IBD
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 2026

Study information
Verified date October 2023
Source Boomerang Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Feasibility study of neuromodulation in patients with IBD.

Description:

The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 40
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility General Inclusion Criteria: - Male or female - 18 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 General Exclusion Criteria (The subject must not meet ANY of the following criteria): - 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Neuromodulation
Neuromodulation

Locations
Country Name City State
United States CU Anschutz Aurora Colorado
United States Las Vegas Medical Research Las Vegas Nevada
United States Phillip Fleshner, Inc. Los Angeles California
United States Columbia University Irving Medical Center New York New York
United States The Mount Sinai Medical Center New York New York
United States Palo Alto Medical Foundation Research Institute Palo Alto California
United States University of Pennsylvania, Perelman School of Medicine Division of Colorectal Surgery Philadelphia Pennsylvania
United States Kansas Gastroenterology Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Boomerang Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease Activity Index CDAI (Crohn's Disease Activity Index Score) or MAYO Score (ulcerative colitis) up to 1 year
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