Inflammatory Bowel Diseases · Ulcerative Colitis
Sacral Neuromodulation for Bowel Urgency in Adults With Ulcerative Colitis
This study is investigating whether an implanted neuromodulation device changes bowel urgency after 12 weeks in adults ages 18 to 85 with ulcerative colitis.
Registry title: BOOM-IBD2 Pivotal Clinical Trial
17 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years–85 Years
- Treatment
- Neuromodulation
- Design
- Not provided
- Central study contact
- Deborah Reasner210-722-6192deb@boomerangmedical.com
- Sponsor
- Boomerang Medical
Research question
Does bowel urgency, measured on a patient-reported 0-to-10 scale, change after 12 weeks of sacral neuromodulation?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 to 85.
- The study is looking for people diagnosed with ulcerative colitis.
- Participants must be able and willing to provide informed consent.
- Participants must be able to follow the study protocol and all follow-up requirements.
Participation overview
What participation may involve
Participants have a neuromodulation device placed during a same-day procedure, report bowel urgency at 12 weeks, and continue study visits for 12 months. What participation may involve: - Undergo placement of a small neuromodulation device beneath the skin during a same-day procedure. - Use an implanted device that sends mild signals to a nerve near the tailbone. - Report bowel-urgency severity at 12 weeks on a scale from 0, no urgency, to 10, worst possible urgency. - Attend follow-up study visits over 12 months. The registry states that study visits continue for 12 months.
Study interventions
What participants may receive or do
- Neuromodulation: Participants receive a small device placed under the skin during a same-day procedure. The device sends mild signals to a nerve near the tailbone.
Study design
How the comparison works
This is an open-label, single-group treatment study in which everyone receives the neuromodulation device. Random assignment is not used because the registry describes one treatment group. There is no masking; participants and study personnel know that the device is being used. The registry reports no separate control or comparison group. There is no placebo group; everyone in the study receives the device.
Reported activities
Procedures and tests
- Placement of the neuromodulation device under the skin during a same-day procedure.
- A patient-reported bowel-urgency assessment at 12 weeks using the Urgency Numeric Rating Scale from 0 to 10.
- Follow-up study visits continuing for 12 months.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 to 85 years old.
- Participants must have a diagnosis of ulcerative colitis.
- Participants must be able and willing to sign the informed consent form.
- Participants must be able to follow the study protocol and willing to complete all follow-up requirements.
- The study accepts male and female participants.
Possible reasons someone may not be able to join
- A significant medical condition that could interfere with study procedures or device operation, or confound the results, may exclude someone.
- An active bacterial infection that risks bacteremia or sepsis, such as an abscess, is exclusionary.
- Active Clostridium difficile infection or active cytomegalovirus infection of the colon is exclusionary.
- Colonic perforation or fulminant colitis requiring emergency surgery is exclusionary.
- Microscopic, ischemic, or infectious colitis is exclusionary.
- Unresected colon neoplasia or current gastrointestinal-tract cancer is exclusionary.
- A colonic stricture that prevents passage of a colonoscope is exclusionary.
- Previous ulcerative-colitis surgery, or being considered likely to need such surgery, is exclusionary.
- A previous neurostimulation implant or participation in a neurostimulation trial is exclusionary.
- Current participation in another clinical trial is exclusionary.
- Participants must be able to operate the device's patient programmer.
Important unknowns
What the record does not make clear
- The registry says visits continue for 12 months but does not report their number, timing, length, or whether any require overnight stays.
- The registry does not state whether participants continue their current ulcerative-colitis treatments during the study.
- The registry does not report whether any medicines must be stopped or changed before device placement.
- The registry does not describe what treatment is available if ulcerative-colitis symptoms worsen during the study.
- A stricture that prevents passage of a colonoscope is exclusionary, but the registry does not say whether screening or follow-up colonoscopy is required.
- The registry does not explain which study procedures, device-related care, or medical costs are paid by the study or billed to insurance.
- The registry does not report whether participants are compensated.
- The registry does not report whether travel, lodging, parking, or related expenses are reimbursed.
- The registry does not state whether any follow-up activities can be completed remotely.
- The registry does not explain whether the device remains implanted after the study, who manages it, or who pays for later device care or removal.
- The registry does not describe the implantation risks, device-programming schedule, or circumstances requiring device adjustment or removal.
Before contacting the site
Questions for the study team
- How many in-person visits are required over the reported 12 months, and how long does each visit take?
- What happens during device placement, what anesthesia is used, and what recovery time or activity restrictions should participants expect?
- What are the known procedure- and device-related risks, and under what circumstances would the device be adjusted or removed?
- Can current ulcerative-colitis medicines continue, and must any medicines be stopped or changed before the procedure?
- What treatment is allowed if ulcerative-colitis symptoms worsen during the study?
- Is colonoscopy or another endoscopic assessment required at screening or during follow-up?
- Which study, device, travel, and medical costs are covered, and is compensation available?
- After the 12-month follow-up, does the device remain implanted, and who manages and pays for future programming, maintenance, replacement, or removal?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis now, and how might a device procedure fit with my current disease activity?
- Would changing or pausing any of my current treatments for this study create concerns, and how should treatment continuity be protected?
- What approved treatment alternatives could address my bowel urgency or overall ulcerative colitis before I consider research participation?
- Are there features of my infection history, colon anatomy, prior surgery, or cancer history that I should discuss with the study team?
- If I contact the study, how should your office and the research team coordinate medication decisions, flare management, procedures, and follow-up care?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
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 and administration
- Organization
- Boomerang Medical
- Organization class
- Industry
- Organization study ID
- BOOM-IBD2 (CIP-B02)
- Lead sponsor
- Boomerang Medical
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Treatment Arm
Patients implanted with neuromodulation
Interventions: Device: Neuromodulation
Interventions
Device
Neuromodulation
Neuromodulation
Eligibility
18 Years–85 Years
All
Not accepted
Inclusion criteria (5)
- Male or femaleRegistry-derived · unreviewed
- 18 to 85 years of ageRegistry-derived · unreviewed
- Diagnosed with ulcerative colitisRegistry-derived · unreviewed
- Ability and willingness to consent to participate by signing the informed consent formRegistry-derived · unreviewed
- Ability to comply with the protocol and willingness to comply with all follow up requirementsRegistry-derived · unreviewed
Exclusion criteria (15)
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the studyRegistry-derived · unreviewed
- Any psychiatric or personality disorder at the discretion of the study investigatorRegistry-derived · unreviewed
- Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)Registry-derived · unreviewed
- Active clostridium difficile infection of the colonRegistry-derived · unreviewed
- Active cytomegalovirus (CMV) infection of the colonRegistry-derived · unreviewed
- Evidence of colonic perforationRegistry-derived · unreviewed
- Fulminant colitis requiring emergency surgeryRegistry-derived · unreviewed
- Microscopic, ischemic or infectious colitisRegistry-derived · unreviewed
- Unresected neoplasia of the colonRegistry-derived · unreviewed
- Colonic stricture unable to pass a colonoscopeRegistry-derived · unreviewed
- Current evidence of cancer in the gastrointestinal tractRegistry-derived · unreviewed
- Current participation in another clinical trialRegistry-derived · unreviewed
- Previous history of surgery for ulcerative colitis, or probably to require such interventionRegistry-derived · unreviewed
- Previously implanted with a neurostimulation device or participated in a neurostimulation trialRegistry-derived · unreviewed
- Inability to operate the patient programmerRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
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.
Recruiting locations in the United States
Gastroenterology Medical Clinic (Objective Health)
RecruitingFolsom, California, 95630, United States
Clinical Trial Coordinator916-226-6044grecia.perez@objective.health
Nazir Rahim, MD
Center for Colorectal Innovation
RecruitingLos Angeles, California, 90048, United States
Clinical Trial Coordinator(310) 289-9224Gayane.Ovsepyan@cshs.org
Karen Zaghiyan
Hoag Hospital
RecruitingNewport Beach, California, 92663, United States
Clinical Trial Coordinator949-764-5597Vianh.Truong@hoag.org
Caroline Hwang
PAMF (Palo Alto Medical Foundation)
RecruitingPalo Alto, California, 94301, United States
Clinical Trial Coordinator510-204-1609myesha.kirk@sutterhealth.org
Ryan McConnell
Kansas Gastro
RecruitingWichita, Kansas, 67226-8119, United States
Clinical Trial Coordinator(316) 730-1029jessica_wewer@ksgastro.com
Michael Lievens, MD
MN Urology
RecruitingWoodbury, Minnesota, 55125, United States
Clinical Research Manager651-999-6903cmckenzie@mnurology.com
Jodi Michaels, MD
GI Alliance
RecruitingJackson, Mississippi, 39232, United States
Clinical Trial Coordinator601-863-0395jesus.monico@gastrodocs.net
Reed Hogan, MD
Gateway GI Research (Objective Health)
RecruitingSt Louis, Missouri, 63141, United States
Clinical Trial Coordinator636-214-5291kristen.strubberg@objective.health
Brian McMorrow, MD
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
RecruitingLas Vegas, Nevada, 89128, United States
Clinical Trial Coordinator+1 702-750-0000betsyj@vectorclinicaltrials.com
Christian Stone
Northwell Health North Shore University Hospital
RecruitingManhasset, New York, 11030, United States
Clinical Trial Coordinator516-504-3955mmanoharan@northwell.edu
Keith Sultan, MD
Columbia University Irving Medical Center/New York Presbyterian Hospital
RecruitingNew York, New York, 10032, United States
Clinical Trial Coordinator212-342-4102eb3709@cumc.columbia.edu
Marco Zoccali, MD
UNC Chapel Hill
RecruitingChapel Hill, North Carolina, 27599, United States
Clinical Trial Coordinator919-843-8105emily_english@med.unc.edu
Millie Long, MD
Pennsylvania Hospital
Not Yet RecruitingPhiladelphia, Pennsylvania, 19107, United States
Clinical Trial Coordinator215-439-1902alice.chen1@pennmedicine.upenn.edu
Joshua Bleier, MD
Columbia Digestive Health Research (Objective Health)
RecruitingColumbia, South Carolina, 29204, United States
Clinical Trial Coordinator803-386-8933marissa.white@objective.health
Edward Kimbrough, MD
Sanford Health
RecruitingSioux Falls, South Dakota, 57105, United States
Clinical Trial Coordinator605-328-1379ashley.puetz@sanfordhealth.org
Kevin Benson, MD
Amarillo Premier Research (Objective Health)
RecruitingAmarillo, Texas, 79106, United States
Clinical Trial Coordinator806-641-0256lauren.kuehler@objective.health
Susan Neese
Digestive Research of Central Texas (Objective Health)
RecruitingWaco, Texas, 76712, United States
(254) 523-4187Victoria.Rico@objective.health
Hanumantha Ancha
Central study contacts
Registry dates
- First posted
- Aug 26, 2024
- Primary completion
- Feb 28, 2027
- Overall completion
- Nov 30, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.