Leiomyoma
Conditions
Keywords
Fibroid Tumor, Fibroid Uterus, Fibroids, Uterine, Fibromyoma, Uterine Neoplasms
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.
Interventions
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.
Sponsors
GAAD Medical Research Institute Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids | 2 years and 9 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed