Boom-IBD Clinical Trial

Boomerang Medical

Status

Active, not recruiting

Conditions

IBD

Treatments

Device: Neuromodulation

Study type

Interventional

Funder types

Industry

Identifiers

Boom-IBD

Details and patient eligibility

About

Feasibility study of neuromodulation in patients with IBD.

Full description

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

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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