CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
AVACEN Thermal Exchange Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01619579
NCT01619579Phase 2Completed
CompareCT.gov

Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study

Avacen, Inc.·interventional·Posted Jun 14, 2012·Updated Feb 1, 2017

In Brief

A Phase 2 clinical trial evaluating AVACEN Thermal Exchange System for Fibromyalgia. Completed, enrolled 22 participants across 1 site.

Detailed Summary

Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. This non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. The change in body temperature may change the sympathetic nervous system's activity and thereby reduce Fibromyalgia pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States
CollaboratorsUniversity of California, San Diego, San Diego Veterans Healthcare System

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 14, 2012
Enrollment StartJun 1, 2011
Primary CompletionMay 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.0 years ago

Interventions

AVACEN Thermal Exchange Systemdevice

Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.