Crohn DiseaseNCT07033208
Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
A study testing Feasibility to obtain thermal variance measurements using a wireless thermal capsule in people with Crohn Disease and Inflammatory Bowel Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases, Healthy
- What is being tested?
- Feasibility to obtain thermal variance measurements using a wireless thermal capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant is 18 -75 years old
- Participant is considered healthy, with no known illnesses
- Participant can follow fasting requirements
- Participant can follow bowel prep instructions
- Participant can provide informed consent
Who cannot join
- Participant is older than 75 years of age
- Participant with current dysphagia or any swallowing disorder
- 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
- Participant with a diagnosis of gastroparesis or small bowel or large bowel dysmotility
- Participant with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding
- Participant with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months
Show all 18Show fewer
- Participant with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs)
- Participants with a known contradiction to metoclopramide
- Participants with a known contraindication to polyethylene glycol
- Participant with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia
- Participant who has had intestinal surgery in the past
- Participant with a history of congestive heart failure
- Participant with Type I or Type II Diabetes
- Participant has a cardiac pacemaker or other implanted electromedical device.
- Participant expected to undergo MRI examination within 7 days after ingestion of the capsule.
- 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
- Participant with delayed gastric emptying
- Participant who is pregnant, suspected pregnant, or is actively breast-feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Anita Chung, 6177244515, tearneylabtrials@partners.org
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.
Read the detailed description
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.
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Healthy
- Being tested
- Feasibility to obtain thermal variance measurements using a wireless thermal capsule
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility to obtain thermal variance measurements using a wireless thermal capsuleDevice
A total of 25 healthy participants will be enrolled in this study all consented participants will receive the same intervention.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | 25 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH Receives: Device: Feasibility to obtain thermal variance measurements using a wireless thermal capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 +/- 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start3 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033208
- Sponsor's protocol ID
- 2023P002565
- Status last verified
- Sep 2026
- First submitted
- 2 May 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance
- ClinicalTrials.gov ID
- NCT07033208
- Acronym / sponsor ID
- 2023P002565
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Device: Feasibility to obtain thermal variance measurements using a wireless thermal capsule25 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is 18 -75 years old
- Participant is considered healthy, with no known illnesses
- Participant can follow fasting requirements
- Participant can follow bowel prep instructions
- Participant can provide informed consent
Key exclusion criteria (18 listed)
- Participant is older than 75 years of age
- Participant with current dysphagia or any swallowing disorder
- 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
- Participant with a diagnosis of gastroparesis or small bowel or large bowel dysmotility
- Participant with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility to obtain thermal variance measurements using a wireless thermal capsuleA total of 25 healthy participants will be enrolled in this study all consented participants will receive the same intervention. | Device | Healthy Volunteers |
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Tearney, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility to obtain thermal variance measurements using a wireless thermal capsule in people with Crohn Disease and Inflammatory Bowel Diseases, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita Chung (6177244515, tearneylabtrials@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Gastrointestinal Temperature Mean Variance in adult study participants as measured by the wireless thermal capsule (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.