Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06571669

BOOM-IBD2 Pivotal Clinical Trial

Led by Boomerang Medical · Updated on 2026-05-13

137

Participants Needed

19

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

BOOM-IBD2 Pivotal Clinical Trial

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female
  • Age 18 to 85 years
  • Diagnosed with ulcerative colitis
  • Able and willing to provide informed consent
  • Able and willing to comply with study protocol and follow-up requirements
Not Eligible

You will not qualify if you...

  • Significant medical conditions interfering with study or device function
  • Psychiatric or personality disorders as determined by investigator
  • Active bacterial infections with risk of bacteremia or sepsis
  • Active Clostridium difficile infection in the colon
  • Active cytomegalovirus infection in the colon
  • Evidence of colonic perforation
  • Fulminant colitis needing emergency surgery
  • Microscopic, ischemic, or infectious colitis
  • Unresected colon neoplasia
  • Colonic stricture blocking colonoscope passage
  • Current gastrointestinal cancer
  • Participation in another clinical trial
  • Previous ulcerative colitis surgery or likely need for it
  • Prior neurostimulation device implantation or trial participation
  • Unable to operate the patient programmer device

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

Gastroenterology Medical Clinic (Objective Health)

Folsom, California, United States, 95630

Actively Recruiting

2

Center for Colorectal Innovation

Los Angeles, California, United States, 90048

Actively Recruiting

3

Hoag Hospital

Newport Beach, California, United States, 92663

Actively Recruiting

4

PAMF (Palo Alto Medical Foundation)

Palo Alto, California, United States, 94301

Actively Recruiting

5

Kansas Gastro

Wichita, Kansas, United States, 67226-8119

Actively Recruiting

6

MN Urology

Woodbury, Minnesota, United States, 55125

Actively Recruiting

7

GI Alliance

Jackson, Mississippi, United States, 39232

Actively Recruiting

8

Gateway GI Research (Objective Health)

St Louis, Missouri, United States, 63141

Actively Recruiting

9

Las Vegas Medical Research LLC, DBA Vector Clinical Trials

Las Vegas, Nevada, United States, 89128

Actively Recruiting

10

Northwell Health North Sore University Hospital

Manhasset, New York, United States, 11030

Not Yet Recruiting

11

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, United States, 10032

Actively Recruiting

12

UNC Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

13

Great Lakes Gastro

Mentor, Ohio, United States, 44060

Actively Recruiting

14

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19107

Not Yet Recruiting

15

Columbia Digestive Health Research (Objective Health)

Columbia, South Carolina, United States, 29204

Actively Recruiting

16

Sanford Health

Sioux Falls, South Dakota, United States, 57105

Actively Recruiting

17

Amarillo Premier Research (Objective Health)

Amarillo, Texas, United States, 79106

Actively Recruiting

18

Digestive Research of Central Texas (Objective Health)

Waco, Texas, United States, 76712

Actively Recruiting

19

Digestive Health Research of North Texas (Objective Health)

Wichita Falls, Texas, United States, 76301

Actively Recruiting

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Research Team

D

Deborah Reasner

CONTACT

B

Bruce Van Deman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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