Boom-IBD Clinical Trial

Feasibility study of neuromodulation in patients with IBD.

Study Overview

• Status: Completed
• Conditions: IBD
• Intervention / Treatment: Device: Neuromodulation

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Phillip Fleshner, Inc.
    • Palo Alto, California, United States, 94301
      • Palo Alto Medical Foundation Research Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • CU Anschutz
  • Kansas
    • Wichita, Kansas, United States, 67226-8119
      • Kansas Gastroenterology
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
    • New York, New York, United States, 10029
      • The Mount Sinai Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania, Perelman School of Medicine Division of Colorectal Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated; Patients implanted with neuromodulation	Device: Neuromodulation; Neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Index	CDAI (Crohn's Disease Activity Index Score) or MAYO Score (ulcerative colitis)	up to 1 year

Collaborators and Investigators

• Sponsor: Boomerang Medical

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): December 6, 2024
• Study Completion (Actual): December 6, 2024

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Boom-IBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No