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Pill Study Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology

NCT02340377 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2015-08-10

No results posted yet for this study

Summary

The primary objective of the proposed study is to determine the use of a wireless method to monitor and record core body temperature during a Whole Body Hyperthermia treatment, compared to an indwelling rectal thermometer.

This protocol is intended to study the differences between a rectal temperature probe and an approved wireless and indigestible thermometer during a WBH session. The current standard in monitoring core body temperature is the usage of an indwelling rectal thermometer. Many patients and potential study subjects, however, decline receiving the treatment, due to the discomfort of using this measuring method and a wireless measuring device would open the possibility for those patients to receive a treatment. The primary endpoint for example of a treatment for MDD is currently defined with reaching a rectal temperature of 38.5 C. However, due to the proximity of the probe to the body's surface, the core body temperature will vary from the rectal temperature and the comparison between the two methods with a validation of the wireless device is necessary.

The investigators will monitor subject's physiological outcome from a single Whole Body Hyperthermia treatment in an open fashion (no placebo/control condition). This study will include safety assessments 7 days several days prior to or same day as the WBH, and include follow-up assessments 1 day and 1 week later.

Conditions

  • Core Body Temperature

Interventions

DEVICE

ELITE 3 HQ

The pill is about the size of a multivitamin, is coated with special medical plastic, and is easy to swallow. The pill sends radio signals to a small recording device that participants wear that send a signal to a monitor and records the participant's internal body temperature. The pill will exit the participant's body in one of his/her bowel movements approximately 1-5 days after ingestion. Pills are not reused.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Charles Raison, MD · University of Arizona, Department of Psychiatry, College of Medicine

  • Clemens Janssen, MS · University of Arizona, Department of Psychiatry, College of Medicine

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02340377 on ClinicalTrials.gov