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History of Changes for Study: NCT01619579
Investigation of Avacen Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)
Latest version (submitted December 5, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 13, 2012 None (earliest Version on record)
2 June 17, 2013 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 July 1, 2013 Study Status
4 July 13, 2015 Sponsor/Collaborators, Study Status, Study Identification, Outcome Measures, Arms and Interventions and Study Design
5 November 30, 2015 Study Status, Outcome Measures, More Information, Eligibility, Adverse Events, Baseline Characteristics, Participant Flow, Conditions and Study Description
6 December 5, 2016 Study Status, Baseline Characteristics and Sponsor/Collaborators
Comparison Format:

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Study NCT01619579
Submitted Date:  June 13, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 110973
Brief Title: Investigation of Avacen Thermal Exchange System for Fibromyalgia Pain (AVACEN: TES)
Official Title: AVACEN for Fibromyalgia: Altering Core Body Temperature to Relieve Pain- An Open Label Study
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2012
Overall Status: Recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: June 12, 2012
First Submitted that
Met QC Criteria:
June 13, 2012
First Posted: June 14, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 13, 2012
Last Update Posted: June 14, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of California, San Diego
Responsible Party: Principal Investigator
Investigator: Tobias Moeller-Bertram
Official Title: Associate Clinical Professor of Anesthesiology
Affiliation: University of California, San Diego
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Hypothesis: Daily use of the AVACEN Thermal Exchange System for 1 month 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.
Detailed Description:
Open or close this module Conditions
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Pain
Non-Invasive
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 15 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment
Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.
Device: AVACEN Thermal Exchange System
Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Improved Pain Ratings
[ Time Frame: 1 month ]

Lower pain ratings after 1 month treatment
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Fibromyalgia diagnosis
  • Over the age of 18
  • Understands English
  • Not pregrant/planning to become pregnant
  • Average pain of 4 or greater over the last week (10 point scale)
  • Fibromyalgia pain lasting longer than 6 months

Exclusion Criteria:

  • Pregnant/Planning to become pregnant
  • Major unstable psychiatric illness
  • Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months
Open or close this module Contacts/Locations
Central Contact Person: Meegin Kincaid, B.S.
Telephone: 858-552-8585 Ext. 2386
Email: mjkincaid@ucsd.edu
Locations: United States, California
VA San Diego
[Recruiting]
La Jolla, California, United States, 92093
Contact:Contact: Meegin Kincaid, B.S. 858-552-8585 Ext. 2386 mjkincaid@ucsd.edu
Contact:Principal Investigator: Tobias Moeller-Bertram, M.D., MAS
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Device manufacturer's website
Description: Primary Investigator Profile
Description: VA San Diego website. Location study is conducted.
Available IPD/Information:

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