top of page
boomIBD2_Logo_RGB.png

An Ulcerative Colitis Study Assessing Bowel Urgency Symptoms in Adults

Take a quick survey to see if you may qualify for a clinical study testing a new treatment designed to reduce bowel urgency.

Living with bowel urgency from UC?

If ulcerative colitis (UC) has you planning around "just in case," it may be bowel urgency: that sudden, hard-to-control need to go.

‍Do urges interrupt work, meals, and even sleep? Studies show that bowel urgency can have a significant impact on daily quality of life for people with UC, even when the disease is otherwise controlled.

Day-to-day impact of bowel urgency [1]

For some people with ulcerative colitis, bowel urgency can affect daily routines, social activities, and emotional well-being. Research has reported associations between bowel urgency, quality of life, and mental-health burden in people with UC.

What is the BOOM-IBD2 Study?

The BOOM-IBD2 clinical research study is evaluating an investigational medical device for adults living with bowel urgency from UC. The goal of this study is to gather important information about how this investigational therapy works and to evaluate its safety and its potential to help manage UC symptoms.

Neuromodulation may offer relief

This research study is exploring a new way to treat bowel urgency symptoms

Study-related support​​​

​

Participants will receive study-related support from trained study staff throughout the trial. An IRB-approved stipend or reimbursement may be available for required clinic visits and study-related travel, as described in the informed consent form.

Investigational device approach​

​

The BOOM-IBD2 study is evaluating an investigational neuromodulation procedure that delivers mild electrical stimulation to nerves involved in bowel function. The study is designed to assess whether this approach may affect bowel urgency symptoms and quality-of-life measures in adults with UC.

Being studied for bowel urgency symptoms​

​

The BOOM-IBD2 study is evaluating whether mild electrical stimulation of nerves involved in bowel function may affect bowel urgency symptoms in adults with UC.

This use is investigational. The safety and effectiveness of the device for this use have not been established.

See If You Qualify

It only takes a minute to find out if you may qualify — your answers could open the door to new treatment options.

How old are you?
17 or younger
18-85
86 or older
Have you been diagnosed with ulcerative colitis by a gastroenterologist, also called a GI doctor?
Yes
No
In the past 24 hours, how would you rate your average bowel urgency (sudden or immediate need to have a bowel movement) on a scale of 0-10 (0 - no urgency, 10 - worst possible urgency)?
0 = no urgency
1
2
3
4
5
6
7
8
9
10 = worst possible urgency
When was your last colonoscopy?
Fewer than 6 months ago
6-11 months ago
1-2 years ago
2-3 years ago
More than 3 years ago
Have you ever been diagnosed with any of the following? Check all that apply.

This clinical research study is evaluating whether a small

device, implanted just under the skin near where the back

pocket on a pair of jeans would sit, can reduce bowel urgency

for people living with ulcerative colitis (UC). The study also

measures how often you have bowel movements, your quality

of life, and your day-to-day activities. The device works by

sending mild electrical pulses to nerves involved in bowel

control. This technology is already FDA-approved and has been

used in over half a million people for other bowel and bladder

conditions.

Based on the information you have today, how interested would you be in participating in a clinical study?
Very interested
Somewhat interested
Not sure
Somewhat disinterested
Very disinterested
What is your biological sex?
Male
Female
Prefer not to say
Which of the following best describes you?

1. Seyedehsan Navabi, Venkata Subhash Gorrepati, Sanjay Yadav, Jaykrishna Chintanaboina, Sarah Maher, Peter Demuth, Benjamin Stern, August Stuart, Andrew Tinsley, Kofi Clarke, Emmanuelle D Williams, Matthew D Coates, Influences and Impact of Anxiety and Depression in the Setting of Inflammatory Bowel Disease, Inflammatory Bowel Diseases, Volume 24, Issue 11, November 2018, Pages 2303–2308, https://doi.org/10.1093/ibd/izy143.

​

2. Singh S, George J, Boland BS, Vande Casteele N, Sandborn WJ. Primary Non-Response to Tumor Necrosis Factor Antagonists is Associated with Inferior Response to Second-line Biologics in Patients with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. J Crohns Colitis. 2018 May 25;12(6):635-643. doi: 10.1093/ecco-jcc/jjy004. PMID: 29370397; PMCID: PMC7189966.

Content on this website is intended for United States residents only. Caution: Investigational device. Limited by Federal (U.S.) law to investigational use only.

​

View study on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06571669

​

CLN-2607-008 Rev A

bottom of page