Far Infrared Radiation Treatment for Uterine Fibroids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Leiomyoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Far Infrared Radiation (5μm to 20μm wavelength)

Intervention Type RADIATION

Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.

Interventions

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Far Infrared Radiation (5μm to 20μm wavelength)

Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.

Intervention Type RADIATION

Other Intervention Names

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Far infrared radiation

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No