RECRUITINGINTERVENTIONAL
BOOM-IBD2 Pivotal Clinical Trial
BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.
About This Trial
The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.
Who May Be Eligible (Plain English)
Who May Qualify:
- Male or female
- 18 to 85 years of age
- Diagnosed with ulcerative colitis
- Ability and willingness to consent to participate by signing the willing to sign a consent form form
- Ability to comply with the protocol and willingness to comply with all follow up requirements
Who Should NOT Join This Trial:
- 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
- Current evidence of cancer in the gastrointestinal tract
- Current participation in another clinical trial
- Previous history of surgery for ulcerative colitis, or probably to require such intervention
- Previously implanted with a neurostimulation device or participated in a neurostimulation trial
- Inability to operate the patient programmer
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Male or female
* 18 to 85 years of age
* Diagnosed with 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
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
* Current evidence of cancer in the gastrointestinal tract
* Current participation in another clinical trial
* Previous history of surgery for ulcerative colitis, or probably to require such intervention
* Previously implanted with a neurostimulation device or participated in a neurostimulation trial
* Inability to operate the patient programmer
Treatments Being Tested
DEVICE
Neuromodulation
Neuromodulation
Locations (10)
Center for Colorectal Innovation
Los Angeles, California, United States
Hoag Hospital
Newport Beach, California, United States
PAMF (Palo Alto Medical Foundation)
Palo Alto, California, United States
Kansas Gastro
Wichita, Kansas, United States
Objective Health - St. Louis
St Louis, Missouri, United States
Las Vegas Medical Research LLC, DBA Vector Clinical Trials
Las Vegas, Nevada, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
New York, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Objective Health - Amarillo
Amarillo, Texas, United States
Objective Health - Central Texas
Waco, Texas, United States