Far Infrared Radiation Treatment for Uterine Fibroids

Leiomyoma Clinical Trial

Official title:

Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00574418
• Other study ID #: GAAD-UF-CTP1
• Status: Active, not recruiting
• Phase: Phase 1
• First received: December 12, 2007
• Last updated: January 2, 2009
• Start date: January 2006
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: GAAD Medical Research Institute Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 2
• Est. completion date: September 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma

Intervention

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

Locations

Country	Name	City	State
Canada	The Centre for Incurable Diseases	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
GAAD Medical Research Institute Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids		2 years and 9 months	No
Secondary	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	No