Ulcerative ColitisNCT06571669
BOOM-IBD2 Pivotal Clinical Trial
A study testing Neuromodulation in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Boomerang Medical at 19 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 19 sitesUnited States
- Study dates
- 31 Jan 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 17 recruiting
- Recruiting
Amarillo Premier Research (Objective Health)
Amarillo, Texas, 79106
Clinical Trial Coordinator, 806-641-0256, lauren.kuehler@objective.health
Susan Neese
- Recruiting
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Clinical Trial Coordinator, 919-843-8105, emily_english@med.unc.edu
Millie Long, MD
- Recruiting
Columbia Digestive Health Research (Objective Health)
Columbia, South Carolina, 29204
Clinical Trial Coordinator, 803-386-8933, marissa.white@objective.health
Edward Kimbrough, MD
- Recruiting
Gastroenterology Medical Clinic (Objective Health)
Folsom, California, 95630
Clinical Trial Coordinator, 916-226-6044, grecia.perez@objective.health
Nazir Rahim, MD
- Recruiting
GI Alliance
Jackson, Mississippi, 39232
Clinical Trial Coordinator, 601-863-0395, jesus.monico@gastrodocs.net
Reed Hogan, MD
- Recruiting
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada, 89128
Clinical Trial Coordinator, +1 702-750-0000 ext. 104, betsyj@vectorclinicaltrials.com
Christian Stone
- Recruiting
Center for Colorectal Innovation
Los Angeles, California, 90048
Clinical Trial Coordinator, (310) 289-9224, Gayane.Ovsepyan@cshs.org
Karen Zaghiyan
- Recruiting
Northwell Health North Shore University Hospital
Manhasset, New York, 11030
Clinical Trial Coordinator, 516-504-3955, mmanoharan@northwell.edu
Keith Sultan, MD
- Withdrawn
Great Lakes Gastro
Mentor, Ohio, 44060
- Recruiting
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Clinical Trial Coordinator, 212-342-4102, eb3709@cumc.columbia.edu
Marco Zoccali, MD
- Recruiting
Hoag Hospital
Newport Beach, California, 92663
Clinical Trial Coordinator, 949-764-5597 ext. 45597, Vianh.Truong@hoag.org
Caroline Hwang
- Recruiting
PAMF (Palo Alto Medical Foundation)
Palo Alto, California, 94301
Clinical Trial Coordinator, 510-204-1609, myesha.kirk@sutterhealth.org
Ryan McConnell
- Not yet recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Clinical Trial Coordinator, 215-439-1902, alice.chen1@pennmedicine.upenn.edu
Joshua Bleier, MD
- Recruiting
Sanford Health
Sioux Falls, South Dakota, 57105
Clinical Trial Coordinator, 605-328-1379, ashley.puetz@sanfordhealth.org
Kevin Benson, MD
- Recruiting
Gateway GI Research (Objective Health)
St Louis, Missouri, 63141
Clinical Trial Coordinator, 636-214-5291, kristen.strubberg@objective.health
Brian McMorrow, MD
- Recruiting
Digestive Research of Central Texas (Objective Health)
Waco, Texas, 76712
(254) 523-4187, Victoria.Rico@objective.health
Hanumantha Ancha
- Recruiting
Kansas Gastro
Wichita, Kansas, 67226-8119
Clinical Trial Coordinator, (316) 730-1029, jessica_wewer@ksgastro.com
Michael Lievens, MD
- Active, not recruiting
Digestive Health Research of North Texas (Objective Health)
Wichita Falls, Texas, 76301
- Recruiting
MN Urology
Woodbury, Minnesota, 55125
Clinical Research Manager, 651-999-6903, cmckenzie@mnurology.com
Jodi Michaels, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Being tested
- Neuromodulation
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromodulationDevice
Neuromodulation
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Patients implanted with neuromodulation Receives: Device: Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Urgency
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start31 Jan 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boomerang Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571669
- Sponsor's protocol ID
- BOOM-IBD2 (CIP-B02)
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2024
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
- ClinicalTrials.gov ID
- NCT06571669
- Acronym / sponsor ID
- BOOM-IBD2 (CIP-B02)
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Boomerang MedicalIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: NeuromodulationPatients implanted with neuromodulation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuromodulationNeuromodulation | Device | Treatment Arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation in people with Ulcerative Colitis and Inflammatory Bowel Diseases, run by Boomerang Medical at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deborah Reasner (210-722-6192, deb@boomerangmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Urgency (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.