Status:
COMPLETED
Boom-IBD Clinical Trial
Lead Sponsor:
Boomerang Medical
Conditions:
IBD
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Feasibility study of neuromodulation in patients with IBD.
Detailed Description
The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.
Eligibility Criteria
Inclusion
- General 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
- 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
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05414955
Start Date
October 1 2022
End Date
December 6 2024
Last Update
June 29 2025
Active Locations (8)
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1
Phillip Fleshner, Inc.
Los Angeles, California, United States, 90048
2
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301
3
CU Anschutz
Aurora, Colorado, United States, 80045
4
Kansas Gastroenterology
Wichita, Kansas, United States, 67226-8119