Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT06571669
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BOOM-IBD2 Pivotal Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 137}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bowel Urgency', 'timeFrame': '12 weeks', 'description': 'Bowel urgency at 12 weeks using the urgency numeric rating scale (URNS). The Urgency NRS is a patient-reported outcome (PRO) that quantifies the severity of bowel urgency on a scale from 0 to 10, where 0 equals no bowel urgency and 10 equals worst possible urgency.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ulcerative Colitis', 'Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* 18 to 85 years of age\n* Diagnosed with ulcerative colitis\n* Ability and willingness to consent to participate by signing the informed consent form\n* Ability to comply with the protocol and willingness to comply with all follow up requirements\n\nExclusion Criteria:\n\n* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study\n* Any psychiatric or personality disorder at the discretion of the study investigator\n* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)\n* Active clostridium difficile infection of the colon\n* Active cytomegalovirus (CMV) infection of the colon\n* Evidence of colonic perforation\n* Fulminant colitis requiring emergency surgery\n* Microscopic, ischemic or infectious colitis\n* Unresected neoplasia of the colon\n* Colonic stricture unable to pass a colonoscope\n* Current evidence of cancer in the gastrointestinal tract\n* Current participation in another clinical trial\n* Previous history of surgery for ulcerative colitis, or probably to require such intervention\n* Previously implanted with a neurostimulation device or participated in a neurostimulation trial\n* Inability to operate the patient programmer'}, 'identificationModule': {'nctId': 'NCT06571669', 'briefTitle': 'BOOM-IBD2 Pivotal Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boomerang Medical'}, 'officialTitle': 'BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.', 'orgStudyIdInfo': {'id': 'BOOM-IBD2 (CIP-B02)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Patients implanted with neuromodulation', 'interventionNames': ['Device: Neuromodulation']}], 'interventions': [{'name': 'Neuromodulation', 'type': 'DEVICE', 'description': 'Neuromodulation', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trial Coordinator', 'role': 'CONTACT', 'email': 'Gayane.Ovsepyan@cshs.org', 'phone': '(310) 289-9224'}, {'name': 'Karen Zaghiyan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for Colorectal Innovation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trial Coordinator', 'role': 'CONTACT', 'email': 'Vianh.Truong@hoag.org', 'phone': '949-764-5597', 'phoneExt': '45597'}, {'name': 'Caroline Hwang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hoag Hospital', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'email': 'jimmin.chang@sutterhealth.org', 'phone': '510-491-6606'}, {'name': 'Ryan McConnell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PAMF (Palo Alto Medical Foundation)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '67226-8119', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'email': 'jessica_wewer@ksgastro.com', 'phone': '(316) 730-1029'}, {'name': 'Michael Lievens, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kansas Gastro', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trial Coordinator', 'role': 'CONTACT', 'email': 'brittany.orick@objective.health', 'phone': '314-779-5885'}, {'name': 'Fred Williams', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Objective Health - St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trial Coordinator', 'role': 'CONTACT', 'email': 'betsyj@vectorclinicaltrials.com', 'phone': '+1 702-750-0222'}, {'name': 'Christian Stone', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Las Vegas Medical Research LLC, DBA Vector Clinical Trials', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Manager', 'role': 'CONTACT', 'email': 'cm2065@cumc.columbia.edu', 'phone': '(212) 342-4102'}, {'name': 'Marco Zoccali', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Columbia University Irving Medical Center/New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599-1350', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trial Coordinator', 'role': 'CONTACT', 'email': 'emily_english@med.unc.edu', 'phone': '919-966-8217'}, {'name': 'Ed Barnes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNC Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trial Coordinator', 'role': 'CONTACT', 'email': 'michelle.hill@objective.health', 'phone': '806-214-2844'}, {'name': 'Susan Neese', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Objective Health - Amarillo', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'krunal.khamkar@objective.health', 'phone': '(254) 523-4187'}, {'name': 'Hanumantha Ancha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Objective Health - Central Texas', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}], 'centralContacts': [{'name': "Malea D'Amico", 'role': 'CONTACT', 'email': 'mdamico@boomerangmedical.com', 'phone': '844-423-9747'}, {'name': 'Colleen Holthe', 'role': 'CONTACT', 'email': 'colleen@boomerangmedical.com', 'phone': '844-423-9747'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boomerang Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}