Boom-IBD Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-12-06

Brief Summary

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Feasibility study of neuromodulation in patients with IBD.

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Detailed Description

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The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.

Conditions

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IBD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treated

Patients implanted with neuromodulation

Group Type EXPERIMENTAL

Neuromodulation

Intervention Type DEVICE

Neuromodulation

Interventions

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Neuromodulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female
* 18 to 75 years of age
* Diagnosed with Crohn's Disease or ulcerative colitis
* Ability and willingness to consent to participate by signing the informed consent form
* Ability to comply with the protocol and willingness to comply with all follow-up requirements
* Still have part or all of their colon

Exclusion Criteria

* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
* Any psychiatric or personality disorder at the discretion of the study investigator
* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
* Active clostridium difficile infection of the colon
* Active cytomegalovirus (CMV) infection of the colon
* Evidence of colonic perforation
* Fulminant colitis requiring emergency surgery
* Microscopic, ischemic or infectious colitis
* Unresected neoplasia of the colon
* Colonic stricture unable to pass a colonoscope
* History of cancer including melanoma (except for localized skin cancers) within 2 years
* Participation in another clinical trial within the past 30 days of device implant
* Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant
* Inability to operate the patient programmer

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No