BOOM-IBD2 Pivotal Clinical Trial

May 11, 2026 updated by: Boomerang Medical

BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.

Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main goal is to find out if bowel urgency gets better after 12 weeks, using a standard rating scale for bowel urgency. Adults ages 18 to 85 with ulcerative colitis may be able to join. Everyone in the study gets the device. There is no placebo group. Study visits continue for 12 months.

Study Type

Interventional

Enrollment (Estimated)

137

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Folsom, California, United States, 95630
        • Recruiting
        • Gastroenterology Medical Clinic (Objective Health)
        • Contact:
        • Principal Investigator:
          • Nazir Rahim, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Center for Colorectal Innovation
        • Contact:
        • Principal Investigator:
          • Karen Zaghiyan
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Hospital
        • Principal Investigator:
          • Caroline Hwang
        • Contact:
      • Palo Alto, California, United States, 94301
        • Recruiting
        • PAMF (Palo Alto Medical Foundation)
        • Principal Investigator:
          • Ryan McConnell
        • Contact:
    • Kansas
      • Wichita, Kansas, United States, 67226-8119
        • Recruiting
        • Kansas Gastro
        • Principal Investigator:
          • Michael Lievens, MD
        • Contact:
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • MN Urology
        • Principal Investigator:
          • Jodi Michaels, MD
        • Contact:
    • Mississippi
      • Jackson, Mississippi, United States, 39232
        • Recruiting
        • GI Alliance
        • Principal Investigator:
          • Reed Hogan, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Gateway GI Research (Objective Health)
        • Contact:
        • Principal Investigator:
          • Brian McMorrow, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Medical Research LLC, DBA Vector Clinical Trials
        • Principal Investigator:
          • Christian Stone
        • Contact:
    • New York
      • Manhasset, New York, United States, 11030
        • Not yet recruiting
        • Northwell Health North Sore University Hospital
        • Contact:
        • Principal Investigator:
          • Keith Sultan, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center/New York Presbyterian Hospital
        • Principal Investigator:
          • Marco Zoccali, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Chapel Hill
        • Principal Investigator:
          • Millie Long, MD
        • Contact:
    • Ohio
      • Mentor, Ohio, United States, 44060
        • Recruiting
        • Great Lakes Gastro
        • Principal Investigator:
          • Keith Friedenberg, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Pennsylvania Hospital
        • Principal Investigator:
          • Joshua Bleier, MD
        • Contact:
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • Columbia Digestive Health Research (Objective Health)
        • Contact:
        • Principal Investigator:
          • Edward Kimbrough, MD
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Sanford Health
        • Principal Investigator:
          • Kevin Benson, MD
        • Contact:
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • Amarillo Premier Research (Objective Health)
        • Principal Investigator:
          • Susan Neese
        • Contact:
      • Waco, Texas, United States, 76712
        • Recruiting
        • Digestive Research of Central Texas (Objective Health)
        • Principal Investigator:
          • Hanumantha Ancha
        • Contact:
      • Wichita Falls, Texas, United States, 76301
        • Recruiting
        • Digestive Health Research of North Texas (Objective Health)
        • Principal Investigator:
          • Louis Wilson, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female
  • 18 to 85 years of age
  • Diagnosed with 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

Exclusion 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
  • Current evidence of cancer in the gastrointestinal tract
  • Current participation in another clinical trial
  • Previous history of surgery for ulcerative colitis, or probably to require such intervention
  • Previously implanted with a neurostimulation device or participated in a neurostimulation trial
  • Inability to operate the patient programmer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel Urgency
Time Frame: 12 weeks
Bowel urgency at 12 weeks using the urgency numeric rating scale (URNS). The Urgency NRS is a patient-reported outcome (PRO) that quantifies the severity of bowel urgency on a scale from 0 to 10, where 0 equals no bowel urgency and 10 equals worst possible urgency.
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Total IBDQ Score
Time Frame: 12 and 52 weeks
12 and 52 weeks
Mayo endoscopic score
Time Frame: 12 and 52 weeks
12 and 52 weeks
Increase in IBDQ score
Time Frame: 12 and 52 weeks
12 and 52 weeks
Rate of device-related SAEs
Time Frame: 4 and 52 weeks
4 and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boomerang Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BOOM-IBD2 (CIP-B02)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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