RECRUITING

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

Conditions

Crohn Disease Inflammatory Bowel Diseases Healthy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-03

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07033208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subject is 18 -75 years old * Subject is considered healthy, with no known illnesses * Subject can follow fasting requirements * Subject can follow bowel prep instructions * Subject can provide informed consent	* Subject is older than 75 years of age * Subject with current dysphagia or any swallowing disorder * Subject 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 * Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility * Subject with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding * Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months * Subject with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs) * Subjects with a known contradiction to metoclopramide * Subjects with a known contraindication to polyethylene glycol * Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia * Subject who has had intestinal surgery in the past * Subject with a history of congestive heart failure * Subject with Type I or Type II Diabetes * Subject has a cardiac pacemaker or other implanted electromedical device. * Subject expected to undergo MRI examination within 7 days after ingestion of the capsule. * Subject 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 * Subject with delayed gastric emptying * Subject who is pregnant, suspected pregnant, or is actively breast-feeding.

Inclusion Criteria

Exclusion Criteria

* Subject is 18 -75 years old
* Subject is considered healthy, with no known illnesses
* Subject can follow fasting requirements
* Subject can follow bowel prep instructions
* Subject can provide informed consent

* Subject is older than 75 years of age
* Subject with current dysphagia or any swallowing disorder
* Subject 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
* Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility
* Subject with a history of inflammatory bowel disease (IBD), intestinal Crohn's disease, chronic constipation, or rectal bleeding
* Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months
* Subject with chronic usage of nonsteroidal anti-inflammatory drugs (NSAIDs)
* Subjects with a known contradiction to metoclopramide
* Subjects with a known contraindication to polyethylene glycol
* Subject with currently suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia
* Subject who has had intestinal surgery in the past
* Subject with a history of congestive heart failure
* Subject with Type I or Type II Diabetes
* Subject has a cardiac pacemaker or other implanted electromedical device.
* Subject expected to undergo MRI examination within 7 days after ingestion of the capsule.
* Subject 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
* Subject with delayed gastric emptying
* Subject who is pregnant, suspected pregnant, or is actively breast-feeding.

Contacts and Locations

Study Contact

Anita Chung

CONTACT

6177244515

tearneylabtrials@partners.org

Principal Investigator

Guillermo Tearney, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Guillermo Tearney, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-03

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2025-06-03

Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

Crohn Disease
Inflammatory Bowel Diseases
Healthy