BOOM-IBD2 Pivotal Clinical Trial

August 5, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Recruiting
        • Northwell Health North Shore 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
        • Withdrawn
        • Great Lakes Gastro
    • 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
        • Active, not recruiting
        • Digestive Health Research of North Texas (Objective Health)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
Patients implanted with neuromodulation
Device: Neuromodulation
Neuromodulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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