Ulcerative Colitis study: Neuromodulation
Official title BOOM-IBD2 Pivotal Clinical Trial
ClinicalTrials.gov ID: NCT06571669
What this study is testing
- What it's testing
- The study aims to determine whether the device can help lessen the urgency to have a bowel movement in patients with ulcerative colitis.
- Who it's for
- The study is looking for adults who have ulcerative colitis.
- What's involved
- Participants will have a small device inserted under the skin in a same‑day procedure. The device sends mild signals to a nerve near the tailbone.
You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Folsom, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Palo Alto, California, United States
- Wichita, Kansas, United States
- Woodbury, Minnesota, United States
- Jackson, Mississippi, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Manhasset, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Columbia, South Carolina, United States
- Sioux Falls, South Dakota, United States
- Amarillo, Texas, United States
- Waco, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Folsom, California, United States; Los Angeles, California, United States; Newport Beach, California, United States; Palo Alto, California, United States; Wichita, Kansas, United States; Woodbury, Minnesota, United States and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.