Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids
18 Years
N/A
Female
Leiomyoma
Trial Information
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for 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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids
Outcome Time Frame:
2 years and 9 months
Safety Issue:
No
Principal Investigator
Ken B Nedd, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
GAAD Medical Research Institute Inc.
Authority:
Canada: Health Canada
Study ID:
GAAD-UF-CTP1
NCT ID:
NCT00574418
Start Date:
January 2006
Completion Date:
September 2008
Related Keywords:
- Leiomyoma
- Fibroid Tumor
- Fibroid Uterus
- Fibroids, Uterine
- Fibromyoma
- Uterine Neoplasms
- Leiomyoma
- Myofibroma
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