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

ConditionsCrohn Disease Inflammatory Bowel Diseases Healthy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Feasibility to obtain thermal variance measurements using a wireless thermal capsule
Device
A total of 25 healthy participants will be enrolled in this study all consented participants will receive the same intervention.

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Healthy VolunteersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Source ClinicalTrials.gov

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