Far Infrared Radiation Treatment for Uterine Fibroids
This trial is active, not recruiting.
|Treatment||far infrared radiation (5μm to 20μm wavelength)|
|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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids
time frame: 2 years and 9 months
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
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)
|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.|
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