BOOM-IBD Clinical Trial
Researchers in the BOOM-IBD Clinical Trial are exploring whether nerve stimulation, a therapy already approved by the FDA to treat other conditions, can be effective for treating IBD.
Who Can Participate?
Could you be eligible for this trial? We’re looking for individuals aged 18-75 with a diagnosis of Crohn’s disease or ulcerative colitis.
Where is the Trial?
Participate in the BOOM-IBD Clinical Trial.
Currently enrolling at sites across the US and adding new sites every day.
Click to find a location near you!
Am I Eligible?
You may qualify for this trial if you:
- Have been diagnosed with Crohn’s disease or ulcerative colitis
- Are between 18 and 75 years of age
- Are on a medication for IBD that isn’t working as well as you would like, or you have never taken any medication for IBD
- Are interested in a device treatment option
- Still have part or all of your colon
There are additional trial requirements to participate. A representative will discuss them with you.
What Is Inflammatory Bowel Disease?
IBD is an umbrella term for disorders that cause chronic inflammation of the gastrointestinal tract. The two most common forms of IBD are Crohn’s disease and ulcerative colitis, and over 3.5 million people in the US have been diagnosed with IBD.1
Ulcerative colitis causes ulcers in the colon and rectum as a result of inflammation. Crohn’s disease can manifest in any region of the digestive system, from the mouth to rectum. This condition can cause inflammation to penetrate the lining and walls of the intestine.
1. Dalhamer, JM et al. Prevalence of inflammatory disease among adults aged ≥ – United States, 2015
Common symptoms of IBD may include:
- Rectal bleeding
- Abdominal pain and cramping
- Reduced appetite
- Weight loss
For some people IBD is only a mild illness, but for others it can be a debilitating condition that leads to life-threatening complications.
About the Trial
The BOOM-IBD Clinical Trial is evaluating sacral nerve stimulation to treat Crohn’s disease and ulcerative colitis using a small implantable medical device. The device uses gentle electrical impulses to activate a nerve pathway in order to reduce inflammation and improve IBD symptoms, and has been granted Breakthrough Device Designation by the FDA for the treatment of Crohn’s disease and ulcerative colitis.
Participation is completely voluntary with no additional cost to you.
Sacral Nerve Stimulation (SNS) is a minimally-invasive surgical procedure in which a small medical device is implanted and sends mild electrical pulses to the sacral nerve located just above the tail bone.
Our research is exploring whether sacral nerve stimulation can activate nerve pathways to help decrease inflammation and symptoms associated with Crohn’s disease and ulcerative colitis.
What to Expect During the Trial
If you choose to join this trial, you’ll need to read and sign an Informed Consent Form (ICF). Afterwards, you will go through a screening process to make sure you’re eligible to participate.
The procedure to implant your device typically will be performed as a same-day outpatient procedure, and does not involve an overnight hospital stay. The nerve stimulator will be placed under the skin, so nothing will show outside your body.
Participants will be followed for 1 year after the procedure through in-person and remote visits.
How Can I Learn More About the Boom-IBD Clinical Trial?
Fill out this questionnaire to see if you or someone you care about meets the requirements.
What is a clinical research trial?
A clinical research trial evaluates the effect of an intervention (use of investigational trial drug, treatment, or device) on specified outcomes (clinical trial goals). In a clinical trial, volunteer participants receive interventions according to the research plan or protocol. When you participate in a clinical trial, you help others by moving medical research forward and gain potential benefits, such as early access to new treatment methods or devices.
Why is the BOOM-IBD Clinical Trial called an “open label” trial?
What is an investigational device?
What are my rights as a participant and what will happen if I decide not to participate?
Your participation in this trial is voluntary. You can decide to stop at any time and you may still be treated at the facility. Your decision whether or not to take part in the trial will not affect your current or future care at the facility.
Tell your trial doctor if you are thinking about stopping or decide to stop. You should talk to the trial doctor about leaving the trial before you decide so that they can find out if you are having any side effects from the investigational device, and they can tell you how to stop safely.
What are my responsibilities while participating in this trial?
Your participation in this trial is completely voluntary and at no cost to you. If you agree to participate, you would be expected to follow the rules and instructions to the best of your ability. If you are not able to follow these rules and instructions, you may be asked to withdraw from the trial.
In order to provide maximum protection for your health, the trial will be under the direct supervision of the trial doctor and will be conducted by trained personnel. You will need to provide all information about your current and past health (medical history) at the Screening Visit and at each Follow-Up Visit, including participation in any other research studies. This information is needed to protect your health.
If you have a personal doctor, it is strongly recommended that you inform them of your interest to participate in this research trial.