Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 1:56 AM
Study NCT ID:
NCT07352995
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermal Measurements of the Gut With a Colonoscope Compatible Thermal Probe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability of thermal probe to collect temperature measurements from colonic mucosa', 'timeFrame': 'Thermal measurements are collected during the study procedure and analyzed within one year of collection.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases', 'Crohn Disease', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to use a modified thermal probe to measure temperature rise in the colonic mucosa of participants with inflammatory bowel disease, Crohn's disease, and/or ulcerative colitis. The main question it aims to answer is:\n\nIs the thermal probe an effective device to use to detect temperature rise in the colonic mucosa?\n\nDuring the participant's standard of care colonoscopy, the thermal probe will be inserted into the colonoscope. The thermal probe is connected to a temperature transmitter that collects and saves the temperature of the colon in real time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants 18 years or older\n* Participants undergoing elective colonoscopy\n* Participants capable of following requirements\n* Participants capable of providing informed consent\n* Participants with a diagnosis of IBD, Crohn's disease, and/or ulcerative colitis or participants undergoing colorectal cancer screening\n\nExclusion Criteria:\n\n* Participants contraindicated for colonoscopy, including experiencing acute events within the last 6 weeks prior to the colonoscopy (i.e. subjects suffering from a myocardial infarction (heart attack), diagnosis of peritonitis (the inflammation of the membrane lining of the abdominal wall), diagnosis of hemodynamic instability (shock), surgery involving colonic anastomosis (reconnection of the colon), and/or bowel injury (from trauma or surgery)\n* Participants who are pregnant"}, 'identificationModule': {'nctId': 'NCT07352995', 'briefTitle': 'Thermal Measurements of the Gut With a Colonoscope Compatible Thermal Probe', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Colonoscopic Investigation of the Correlation Between Bowel Wall Inflammation and Luminal Temperature Rise in IBD', 'orgStudyIdInfo': {'id': '2025P000709'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "IBD, Crohn's Disease, and/or UC", 'description': "10 adult participants currently diagnosed with inflammatory bowel disease (IBD), Crohn's disease, and/or ulcerative colitis (UC) will be enrolled at MGH", 'interventionNames': ['Device: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa']}, {'type': 'EXPERIMENTAL', 'label': 'Undergoing Colorectal Screening', 'description': '10 adult subjects undergoing colorectal cancer screening will be enrolled at MGH', 'interventionNames': ['Device: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa']}], 'interventions': [{'name': 'Feasibility of using a thermal probe to measure temperature rise in colonic mucosa', 'type': 'DEVICE', 'description': '10 participants in each arm will be enrolled in this study. All consented participants will receive the same intervention.', 'armGroupLabels': ["IBD, Crohn's Disease, and/or UC", 'Undergoing Colorectal Screening']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Anita Chung', 'role': 'CONTACT', 'email': 'Tearneylabtrials@partners.org', 'phone': '617-643-6092'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Anita Chung', 'role': 'CONTACT', 'email': 'Tearneylabtrials@partners.org', 'phone': '617-643-6092'}], 'overallOfficials': [{'name': 'Guillermo Tearney, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Leona M. and Harry B. Helmsley Charitable Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Guillermo Tearney', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}