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NCT02340377 · ClinicalTrials.gov registry record
Pill Study Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology
A clinical trial, sponsored by University of Arizona.
- Terminated
- Registry status
- 30
- Enrollment target
NCT02340377: Clinical Trial study, sponsored by University of Arizona.
NCT02340377 is a clinical trial that was terminated before completion, run by University of Arizona. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02340377 was terminated before completion, sponsored by University of Arizona.
- TERMINATED
- Registry status
- 30 participants
- Enrollment target
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.
Primary Outcome
Core body temperature differences as measured by 1) a rectal temperature probe and 2) an approved wireless and indigestible thermometer during a WBH session.
Interventions
- DEVICE ELITE 3 HQ
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-01 |
| Est. Completion | 2015-06 |
Why NCT02340377 stopped before completion
NCT02340377 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ELITE 3 HQ is the first listed.
NCT02340377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02340377 about?
NCT02340377 is a clinical study titled "Pill Study Hyperthermia Device (Heckel HT 3000): Monitoring Core Body Temperature Using Wireless Technology". 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 temperat...
What is the current status of trial NCT02340377?
This trial is currently terminated. The enrollment target is 30 participants. The study started on 2015-01. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02340377?
The interventions under investigation include: ELITE 3 HQ (DEVICE).
Who is sponsoring clinical trial NCT02340377?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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