Crohn Disease · Healthy · Inflammatory Bowel Diseases
Wireless Thermal Capsule Study in Healthy Adults
This feasibility study asks whether a swallowed wireless thermal capsule can transmit valid temperature data while traveling through the gastrointestinal tract of healthy adults.
Registry title: Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–75 Years
- Treatment
- Feasibility to obtain thermal variance measurements using a wireless thermal capsule
- Design
- Not provided
- Central study contact
- Anita Chung6177244515tearneylabtrials@partners.org
- Sponsor
- Massachusetts General Hospital
Research question
Can the wireless thermal capsule feasibly collect and transmit valid temperature information while passing through the gastrointestinal tract of healthy adults?
Participant snapshot
Who the study is looking for
- The study is looking for healthy adults ages 18 through 75.
- The study is looking for people with no known illnesses or pre-existing gastrointestinal disorders.
- The study is looking for people who can follow fasting and bowel-preparation instructions.
- The study is enrolling people at Massachusetts General Hospital in Boston.
Participation overview
What participation may involve
Participants complete bowel preparation, wear a receiver belt and eight abdominal antennas, swallow the capsule, and are monitored while it travels through the gastrointestinal tract. What participation may involve: - Follow bowel-preparation instructions beginning three days before the scheduled procedure; fasting and laxative mixtures may also be requested. - Wear a receiver belt and eight antennas placed on the abdomen by study staff. - Attempt to swallow the wireless thermal capsule, with up to 10 attempts and optional swallowing aids. - Remain at the research center for hourly monitoring and collection of capsule temperature and position-tracking data. - If the capsule has not passed before discharge, self-monitor at home and provide visual confirmation of passage if requested. The bowel preparation starts three days before the procedure. Participants stay at the center for up to 16 hours or until the capsule passes, whichever occurs first, and are followed until passage; medical intervention may be requested if passage is not confirmed after two weeks. The registry describes a scheduled procedure at Massachusetts General Hospital and a possible return for medical intervention if capsule passage is not confirmed after two weeks, but it does not give a complete visit schedule.
Study interventions
What participants may receive or do
- Feasibility to obtain thermal variance measurements using a wireless thermal capsule: All participants swallow a wireless thermal capsule that transmits temperature and position-tracking data as it travels through the gastrointestinal tract.
Study design
How the comparison works
This is an open-label, single-group device-feasibility study in which an estimated 10 healthy adults receive the same capsule intervention. The registry marks allocation as not applicable because there is one study group. There is no masking; participants and study staff are not described as blinded. The registry describes only one experimental group and does not report a separate control or comparator group. No placebo or sham intervention is listed; all consented participants receive the same capsule intervention.
Reported activities
Procedures and tests
- Standard-of-care bowel preparation beginning three days before the procedure.
- Possible fasting for several hours and consumption of laxative preparation mixtures.
- Placement of a receiver belt and eight antennas on the abdomen.
- Swallowing the wireless thermal capsule, with up to 10 attempts and optional swallowing aids such as PillGlide or Chloraseptic.
- Hourly monitoring while the capsule transmits temperature and position-tracking data.
- Possible administration of metoclopramide or polyethylene glycol to help move the capsule through the gastrointestinal tract.
- Self-monitoring after discharge and possible visual confirmation that the capsule passed in stool.
- Possible return to Massachusetts General Hospital for medical intervention if capsule passage is not confirmed after two weeks.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 75 years old.
- Participants must be considered healthy and have no known illnesses.
- Participants must be able to follow the fasting requirements.
- Participants must be able to follow the bowel-preparation instructions.
- Participants must be able to provide informed consent.
Possible reasons someone may not be able to join
- People with current difficulty swallowing or another swallowing disorder are excluded.
- People with a condition believed to increase capsule-retention risk—such as gastrointestinal strictures, intestinal tumors, bowel obstruction, incomplete colonoscopies, or fistula—are excluded.
- People with gastroparesis, delayed gastric emptying, or small- or large-bowel motility disorders are excluded.
- People with a history of inflammatory bowel disease, intestinal Crohn's disease, chronic constipation, or rectal bleeding are excluded.
- People with current suspected or diagnosed blood in stool, black stools, or iron deficiency with or without anemia are excluded.
- People who have previously had intestinal surgery are excluded.
- People with a cardiac pacemaker or another implanted electromedical device are excluded.
- People expected to have magnetic resonance imaging within seven days after swallowing the capsule are excluded.
- People with a known contraindication to metoclopramide or polyethylene glycol are excluded.
- People who are pregnant, suspected to be pregnant, or actively breastfeeding are excluded.
Important unknowns
What the record does not make clear
- The registry describes the procedure-day stay and a possible return if the capsule has not passed, but it does not provide a complete schedule or total number of visits.
- The registry does not explain whether participants must continue, pause, or change routine medications around the bowel preparation and capsule procedure.
- The registry mentions physician consultation for new gastrointestinal symptoms and possible medical intervention if capsule passage is not confirmed after two weeks, but it does not specify the intervention.
- The registry does not state which study-related or medical costs are covered or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report reimbursement or support for travel, parking, meals, or lodging.
- The registry lists Crohn Disease and inflammatory bowel diseases as conditions, but the study arm seeks healthy adults and the eligibility criteria exclude people with inflammatory bowel disease or intestinal Crohn's disease.
Before contacting the site
Questions for the study team
- How many in-person visits and follow-up contacts are expected from screening until capsule passage is confirmed?
- Which routine medicines or supplements must be continued, paused, or adjusted around the bowel preparation and procedure?
- What happens if the capsule does not pass, and what medical intervention might be needed after two weeks?
- Which study-related or medical costs are covered, and could any charges be billed to the participant or insurance?
- Are compensation or reimbursements available for time, travel, parking, meals, or lodging?
- Is this study enrolling only healthy volunteers, despite listing Crohn disease and inflammatory bowel diseases as conditions?
Before changing care
Questions for your gastroenterologist
- Could the bowel preparation, fasting, capsule, metoclopramide, or polyethylene glycol pose concerns given my health history and current medicines?
- Would any of my current treatments need to change around the procedure, and how could changes be coordinated safely with the research team?
- Do I have any history or symptoms that could increase the risk of swallowing difficulty or capsule retention?
- If the capsule does not pass or gastrointestinal symptoms occur, how should my care be coordinated between you and the study physician?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
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. Participants will be given a bed to sit in the Translational and Clinical Research Center at MGH. After informed consent, a receiver belt and 8 antennas will be placed on the subjects 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 research study team will monitor the subject hourly and collect thermal and position tracking data from the WTC as it travels the GI tract and is excreted in their stools. The participant will be asked to stay for up to 16 hrs or until the capsule has been passed, which ever is earlier. 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 16 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.
Study design and administration
- Organization
- Massachusetts General Hospital
- Organization class
- Other
- Organization study ID
- 2023P002565
- Lead sponsor
- Massachusetts General Hospital
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Device Feasibility
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Healthy Volunteers
10 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH
Interventions: Device: Feasibility to obtain thermal variance measurements using a wireless thermal capsule
Interventions
Device
Feasibility to obtain thermal variance measurements using a wireless thermal capsule
A total of 10 healthy participants will be enrolled in this study all consented participants will receive the same intervention.
Eligibility
18 Years–75 Years
All
Accepted
Inclusion criteria (5)
- Participant is 18 -75 years oldRegistry-derived · unreviewed
- Participant is considered healthy, with no known illnessesRegistry-derived · unreviewed
- Participant can follow fasting requirementsRegistry-derived · unreviewed
- Participant can follow bowel prep instructionsRegistry-derived · unreviewed
- Participant can provide informed consentRegistry-derived · unreviewed
Exclusion criteria (18)
- Participant is older than 75 years of ageRegistry-derived · unreviewed
- Participant with current dysphagia or any swallowing disorderRegistry-derived · unreviewed
- 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 fistulaRegistry-derived · unreviewed
- Participant with a diagnosis of gastroparesis or small bowel or large bowel dysmotilityRegistry-derived · unreviewed
- Participant with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleedingRegistry-derived · unreviewed
- Participant with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 monthsRegistry-derived · unreviewed
- Participant with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs)Registry-derived · unreviewed
- Participants with a known contradiction to metoclopramideRegistry-derived · unreviewed
- Participants with a known contraindication to polyethylene glycolRegistry-derived · unreviewed
- Participant with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemiaRegistry-derived · unreviewed
- Participant who has had intestinal surgery in the pastRegistry-derived · unreviewed
- Participant with a history of congestive heart failureRegistry-derived · unreviewed
- Participant with Type I or Type II DiabetesRegistry-derived · unreviewed
- Participant has a cardiac pacemaker or other implanted electromedical device.Registry-derived · unreviewed
- Participant expected to undergo MRI examination within 7 days after ingestion of the capsule.Registry-derived · unreviewed
- 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 studyRegistry-derived · unreviewed
- Participant with delayed gastric emptyingRegistry-derived · unreviewed
- Participant who is pregnant, suspected pregnant, or is actively breast-feeding.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Measurement of Gastrointestinal Temperature Mean Variance in adult study participants as measured by the wireless thermal capsule
Time frame: 2 weeks
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 +/- 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.
Recruiting locations in the United States
Massachusetts General Hospital
RecruitingBoston, Massachusetts, 02114, United States
Anita Chung6177244515tearneylabtrials@partners.org
Central study contacts
Registry dates
- First posted
- Jun 24, 2025
- Primary completion
- Apr 30, 2027
- Overall completion
- Apr 30, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.