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
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• IBD

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