Neuromodulation for Inflammatory Bowel Disease

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Boomerang Medical

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

Feasibility study of neuromodulation in patients with IBD.

Research Team

Eligibility Criteria

Adults aged 18-75 with Inflammatory Bowel Disease for at least 6 months can join this trial if they're able to sign consent and follow the study plan. People with active infections, recent emergency surgery needs, colon issues like perforation or neoplasia, psychiatric disorders that could affect participation, a history of cancer within two years (except some skin cancers), drug abuse, or those in another trial recently cannot participate.

Inclusion Criteria

I am either male or female.

I have been diagnosed with Crohn's Disease or ulcerative colitis.

I can follow the study's requirements and will attend all follow-up appointments.

Exclusion Criteria

I do not have any active infections that could lead to sepsis.

I needed emergency surgery for severe colitis.

I have an active C. difficile infection in my colon.

Treatment Details

Interventions

• Neuromodulation (Neuromodulation Device)

Trial Overview The Boom-IBD Clinical Trial is testing how well neuromodulation works as a treatment for patients with IBD. It's an early-stage study to see if the method is practical and safe before it can be tested more widely.

Participant Groups

Group I: Treated Experimental Treatment 1 Intervention

Patients implanted with neuromodulation

Neuromodulation is already approved in Canada, Japan for the following indications:

Approved in Canada as Neuromodulation Therapy for:

• Chronic Neuropathic Pain
• Epilepsy
• Parkinson's Disease

Approved in Japan as Neuromodulation Therapy for:

• Chronic Neuropathic Pain
• Parkinson's Disease

Who Is Running the Clinical Trial?

Boomerang Medical

Lead Sponsor

Trials

2

Recruited

180+