Far Infrared Radiation Treatment for Uterine Fibroids
Phase 1
- Conditions
- Leiomyoma
- Interventions
- Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
- Registration Number
- NCT00574418
- Lead Sponsor
- GAAD Medical Research Institute Inc.
- Brief Summary
A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 2
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Far Infrared Radiation (5μm to 20μm wavelength) -
- Primary Outcome Measures
Name Time Method The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids 2 years and 9 months
- Secondary Outcome Measures
Name Time Method 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. Two years and nine months
Trial Locations
- Locations (1)
The Centre for Incurable Diseases
🇨🇦Toronto, Ontario, Canada