[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595496":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":13,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":13,"studyType":79,"phases":80,"briefSummary":81,"conditions":82,"keywords":13,"overallStatus":46,"whyStopped":13,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Measurement of Gastrointestinal Temperature Mean Variance in adult study participants as measured by the wireless thermal capsule","This is a pilot study to demonstrate that the capsule can transmit valid temperature data from within the gastrointestinal tract. Since the study participants are nominally healthy, we anticipate that on a per patient basis, the capsule will detect a core body temperature with a mean variance (σ\\^2) of +\u002F- 0.5°C. With a study size of 10 participants, the measured mean variance 95% confidence intervals will be 0.24≤σ\\^2≤1.6 °C, which is sufficient to demonstrate that the capsule transmits valid gastrointestinal tract temperature data.","2 weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","DEVICE_FEASIBILITY",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","The purpose of this study is to determine the feasibility of using the wireless thermal capsule (WTC) to collect temperature information from the human GI tract in healthy adult subjects. Participants will be asked to do a standard of care bowel prep with instructions to start the prep three days before their scheduled procedure. Participants may also be asked to fast for several hours and consume a series of laxative prep mixtures. This is a two visit study, during the first study visit, informed consent will be collected. Afterwards, a receiver belt and 8 antennas will be placed on the subject's abdomen by trained study staff. The participant will be asked to swallow the WTC capsule, and will have 10 attempts to try to swallow the capsule. They may be also offered optional swallowing aids such as PillGlide or Chloraseptic to help swallow the capsule. If the participant is not able to swallow the capsule after 10 attempts, the research procedure will be terminated. Once the WTC has been swallowed, the subject will be able to go home and will be asked to complete a Participant Daily Record. A member of the study staff may communicate with the subject every few days until the subject has excreted the capsule in their stool or until 50 hours have passed. The second study visit occurs after 50 hours, the subject will return the receiver belt, and Participant Daily Record. Should the participant experience any new symptoms that could indicate a problem in the GI tract, (abdominal discomfort, blood in stool, nausea), a physician will be consulted. The participant may be asked to consume drugs such as metoclopramide or polyethylene glycol to help move the capsule along in their gut. If the capsule hasn't been passed after 50 hours, the participant may be cleared to return home if they have no other symptoms, and may be asked to self monitor until the capsule has passed. The study team will follow up with the participant until the capsule has passed, and the participant may be asked to provide visual confirmation that the capsule has been successfully passed at home. If passage is not confirmed after 2 weeks, the participant may be asked to return to MGH for medical intervention.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Healthy Volunteers","EXPERIMENTAL","25 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH",[27],"Device: Feasibility to obtain thermal variance measurements using a wireless thermal capsule",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"DEVICE","Feasibility to obtain thermal variance measurements using a wireless thermal capsule","A total of 25 healthy participants will be enrolled in this study all consented participants will receive the same intervention.",[23],[35],{"name":36,"affiliation":5,"role":37},"Guillermo Tearney, MD, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},"Anita Chung","CONTACT","6177244515","tearneylabtrials@partners.org",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-71.05977,42.35843,{"lat":56,"lon":55},[59],{"name":40,"role":41,"phone":42,"phoneExt":13,"email":43},{"type":37,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Guillermo Tearney","Principal Investigator - MD, PhD, FACC, FCAP, FNAI",[64],{"name":65,"class":6},"The Leona M. and Harry B. Helmsley Charitable Trust","100595496","feasibility-of-a-wireless-thermal-capsule-endoscopy-to-detect-gastrointestinal-thermal-variance-100595496",false,"NCT07033208","Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance","Inclusion Criteria:\n\n* Participant is 18 -75 years old\n* Participant is considered healthy, with no known illnesses\n* Participant can follow fasting requirements\n* Participant can follow bowel prep instructions\n* Participant can provide informed consent\n\nExclusion Criteria:\n\n* Participant is older than 75 years of age\n* Participant with current dysphagia or any swallowing disorder\n* Participant with any current condition believed to have an increased risk of capsule retention such as gastrointestinal strictures, intestinal tumors, bowel obstruction, incomplete colonoscopies or fistula\n* Participant with a diagnosis of gastroparesis or small bowel or large bowel dysmotility\n* Participant with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding\n* Participant with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months\n* Participant with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs)\n* Participants with a known contradiction to metoclopramide\n* Participants with a known contraindication to polyethylene glycol\n* Participant with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia\n* Participant who has had intestinal surgery in the past\n* Participant with a history of congestive heart failure\n* Participant with Type I or Type II Diabetes\n* Participant has a cardiac pacemaker or other implanted electromedical device.\n* Participant expected to undergo MRI examination within 7 days after ingestion of the capsule.\n* Participant has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study\n* Participant with delayed gastric emptying\n* Participant who is pregnant, suspected pregnant, or is actively breast-feeding.",true,"ALL","18 Years","75 Years",{"count":77,"type":78},25,"ESTIMATED","INTERVENTIONAL",[15],"The goal of this research is to learn how a new device called the wireless thermal capsule (WTC) can collect thermal data to help see diseases that happen in the gastrointestinal (GI) tract, such as Crohn's Disease.",[83,84,85],"Crohn Disease","Inflammatory Bowel Diseases","Healthy","2026-09-29",{"date":88,"type":89},"2026-10-02","ACTUAL",{"date":91,"type":89},"2025-06-03",{"date":93,"type":78},"2027-04-30",{"name":5,"class":6},1]