Boom-IBD Clinical Trial

  • STATUS
    Recruiting
  • End date
    Dec 10, 2026
  • participants needed
    10
  • sponsor
    Boomerang Medical
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Updated on 10 April 2023
See if I qualify

Summary

Early feasibility study of neuromodulation in patients with IBD.

Description

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

Details
Condition IBD
Treatment neuromodulation
Clinical Study IdentifierNCT05414955
SponsorBoomerang Medical
Last Modified on10 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female
to 75 years of age
Disease duration of ≥ 6 months
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
General Exclusion Criteria (The subject must not meet ANY of the following
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
History or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications
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
History of proctocolectomy
Colonic stricture unable to pass a colonoscope
Active or latent tuberculosis
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
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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