This trial is active, not recruiting.

Condition leiomyoma
Treatment far infrared radiation (5μm to 20μm wavelength)
Phase phase 1
Sponsor GAAD Medical Research Institute Inc.
Start date January 2006
End date March 2008
Trial size 2 participants
Trial identifier NCT00574418, GAAD-UF-CTP1


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
far infrared radiation (5μm to 20μm wavelength) Far infrared radiation
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.

Primary Outcomes

The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids
time frame: 2 years and 9 months

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids
Principal investigator Ken B Nedd, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2009.
Information provided to ClinicalTrials.gov by GAAD Medical Research Institute Inc..