Far Infrared Radiation Treatment for Uterine Fibroids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by GAAD Medical Research Institute Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
GAAD Medical Research Institute Inc.
ClinicalTrials.gov Identifier:
NCT00574418
First received: December 12, 2007
Last updated: January 2, 2009
Last verified: January 2009

December 12, 2007
January 2, 2009
January 2006
March 2008   (final data collection date for primary outcome measure)
The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids [ Time Frame: 2 years and 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574418 on ClinicalTrials.gov Archive Site
The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other related uterine conditions, for example, bleeding. [ Time Frame: Two years and nine months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Far Infrared Radiation Treatment for Uterine Fibroids
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids

A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.

Uterine fibroids are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape and often highly vascular. On MR imaging exams, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid.

We are postulating that energy specific electromagnetic radiation of the uterus will shrink the benign tumors.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leiomyoma
Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.
Other Name: Far infrared radiation
1
Intervention: Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2
September 2008
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women age 18 or older with symptomatic fibroids

Exclusion Criteria:

  • Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
  • Metallic implants that are incompatible with MRI or ultrasound
  • Known intolerance to the MRI contrast agent (e.g. Gadolinium)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00574418
GAAD-UF-CTP1
Yes
Dr. Kwasi Donyina/Founder & President, GAAD Medical Research Institute Inc.
GAAD Medical Research Institute Inc.
Not Provided
Principal Investigator: Ken B Nedd, M.D. GAAD Medical Research Institute Inc.
Study Director: Kwasi Donyina, Ph.D. GAAD Medical Research Institute Inc.
GAAD Medical Research Institute Inc.
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP