Feasibility of a Wireless Thermal Capsule Endoscopy to Detect Gastrointestinal Thermal Variance

NCT07033208 | Recruiting FDA Device

• 1 other identifier: 2023P002565
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

10 healthy adult participants with no pre-existing gastrointestinal disorders will be enrolled at MGH

Device: Feasibility to obtain thermal variance measurements using a wireless thermal capsule

Interventions

Feasibility to obtain thermal variance measurements using a wireless thermal capsule DEVICE

A total of 10 healthy participants will be enrolled in this study all consented participants will receive the same intervention.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Guillermo Tearney, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Chung

CONTACT

6177244515; tearneylabtrials@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: June 24, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)