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BOOM-IBD2 Pivotal Clinical Trial

NCT06571669 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2026-05-13

No results posted yet for this study

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. It is placed during a same-day procedure.

Conditions

Interventions

DEVICE

Neuromodulation

Neuromodulation

Sponsors & Collaborators

  • Boomerang Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2027-02-28
Completion
2027-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571669 on ClinicalTrials.gov