Far Infrared Radiation Treatment for Uterine Fibroids

GAAD Medical Research Institute Inc.

Status and phase: Unknown; Phase 1

Conditions: Leiomyoma

Treatments: Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Study type: Interventional

Funder types: Other

Identifiers

NCT00574418

GAAD-UF-CTP1

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

1

Other group

Treatment:

Radiation: Far Infrared Radiation (5μm to 20μm wavelength)