Does Ulcerative Colitis disrupt your daily life?

A clinical trial to evaluate whether nerve stimulation may play a role in ulcerative colitis is now enrolling.

See If You Qualify

What Is This Trial About?

Researchers in the BOOM-IBD2 clinical trial are studying whether a small medical device that gently stimulates nerves connected to the gut can have an effect in people with ulcerative colitis. Boomerang Medical is conducting this clinical trial to evaluate the impact of this therapy over a 12-month period through a combination of in-person and telehealth visits.

If you’re eligible for the study, you would receive the investigational treatment. There’s no separate group getting a placebo or different treatment.

Participation in the BOOM-IBD2 study is voluntary. There is no cost to join. You may be reimbursed for certain study-related expenses, which will be discussed with the study team.

Who Can Join This Study?

You may qualify if you:

  • Have been diagnosed with ulcerative colitis by a medical professional
  • Are between 18 and 85 years old
  • Are not currently participating in another clinical trial

Study staff will determine full eligibility based on additional study criteria.

Check My Eligibility

How Can I Learn More About the Boom-IBD2 Clinical Trial?

Fill out this questionnaire to see if you or someone you care about meets the requirements.

A representative from the BOOM-IBD2 Clinical Trial will get in touch with you to talk about any other eligibility criteria.

"*" indicates required fields

Have you been diagnosed with ulcerative colitis (UC) by a medical professional?
Have you had a colectomy or do you plan to have one?
Are you between the ages of 18 and 85?
Do you have any medical condition that would make it unsafe for you to have a minimally-invasive surgery under general anesthesia?
Future Studies Consent
Contact Consent*
Privacy Policy Consent*
This field is for validation purposes and should be left unchanged.

What to Expect During the Trial

Screening:

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.

Procedure:

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.

Follow-Up:

Participants will be followed for 1 year after the procedure through in-person and remote visits.

Common Questions

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.

What is an investigational device?
An investigational device has not been approved by the U.S. Food and Drug Administration (FDA) for the indication being studied but is allowed to be used on people for research purposes.
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.

How can I learn more about the investigational device and this trial?

More information on the BOOM-IBD2 Clinical Trial can be found on clinicaltrials.gov.

Trial Site Locations

Current trial locations are listed below and more may be added at any time.

If you are interested in participating in this trial complete the form to speak with a trial representative regarding your eligibility and available trial locations.

      Help spread awareness of the BOOM-IBD2 Clinical Trial by sharing with others!

      To share this study information via email, click here.

      Are you a physician looking to refer a patient to the BOOM-IBD2 Clinical Trial?

      Please contact a trial representative at (800) 411-8819 or info@boomerangmedical.com for more information.