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Neuromodulation Device

Neuromodulation for Inflammatory Bowel Disease

N/A
Waitlist Available
Research Sponsored by Boomerang Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with Crohn's Disease or ulcerative colitis
Aged 18 to 75 years
Must not have
Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
Fulminant colitis requiring emergency surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trialtested a new type of therapy to help people with inflammatory bowel disease (IBD).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is a feasibility study focusing on neuromodulation in IBD patients, specific side effects are not listed but may include discomfort from the device or procedure-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Crohn's Disease or ulcerative colitis.
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I am between 18 and 75 years old.
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I still have part or all of my colon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any active infections that could lead to sepsis.
Select...
I needed emergency surgery for severe colitis.
Select...
I have an active C. difficile infection in my colon.
Select...
I have an active CMV infection in my colon.
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My colon cancer has not been surgically removed.
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I haven't had any cancer, except for skin cancer, in the past 2 years.
Select...
I have been diagnosed with a type of colitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease Activity Index

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatedExperimental Treatment1 Intervention
Patients implanted with neuromodulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neuromodulation
2022
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

Boomerang MedicalLead Sponsor
1 Previous Clinical Trials
137 Total Patients Enrolled

Media Library

Neuromodulation (Neuromodulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05414955 — N/A
Inflammatory Bowel Disease Research Study Groups: Treated
Inflammatory Bowel Disease Clinical Trial 2023: Neuromodulation Highlights & Side Effects. Trial Name: NCT05414955 — N/A
Neuromodulation (Neuromodulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05414955 — N/A
~0 spots leftby Dec 2024
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