BOOM-IBD2 Pivotal Clinical Trial
BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
1 other identifier
interventional
137
1 country
10
Brief Summary
The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedStudy Start
First participant enrolled
January 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedJuly 3, 2025
July 1, 2025
1 year
August 23, 2024
July 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Study Arms (1)
Treatment Arm
EXPERIMENTALPatients implanted with neuromodulation
Interventions
Eligibility Criteria
You may qualify if:
- Male or female
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Center for Colorectal Innovation
Los Angeles, California, 90048, United States
Hoag Hospital
Newport Beach, California, 92663, United States
PAMF (Palo Alto Medical Foundation)
Palo Alto, California, 94301, United States
Kansas Gastro
Wichita, Kansas, 67226-8119, United States
Objective Health - St. Louis
St Louis, Missouri, 63141, United States
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada, 89113, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599-1350, United States
Objective Health - Amarillo
Amarillo, Texas, 79106, United States
Objective Health - Central Texas
Waco, Texas, 76712, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
August 26, 2024
Study Start
January 31, 2025
Primary Completion
February 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
July 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share