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Far Infrared Radiation Treatment for Uterine Fibroids

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by GAAD Medical Research Institute Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00574418
First Posted: December 17, 2007
Last Update Posted: January 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GAAD Medical Research Institute Inc.
  Purpose
A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.

Condition Intervention Phase
Leiomyoma Radiation: Far Infrared Radiation (5μm to 20μm wavelength) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids

Further study details as provided by GAAD Medical Research Institute Inc.:

Primary Outcome Measures:
  • The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids [ Time Frame: 2 years and 9 months ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Two years and nine months ]

Enrollment: 2
Study Start Date: January 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Radiation: Far Infrared Radiation (5μm to 20μm wavelength)
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.
Other Name: Far infrared radiation

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574418


Locations
Canada, Ontario
The Centre for Incurable Diseases
Toronto, Ontario, Canada, M4V 1L5
Sponsors and Collaborators
GAAD Medical Research Institute Inc.
Investigators
Principal Investigator: Ken B Nedd, M.D. GAAD Medical Research Institute Inc.
Study Director: Kwasi Donyina, Ph.D. GAAD Medical Research Institute Inc.
  More Information

Responsible Party: Dr. Kwasi Donyina/Founder & President, GAAD Medical Research Institute Inc.
ClinicalTrials.gov Identifier: NCT00574418     History of Changes
Other Study ID Numbers: GAAD-UF-CTP1
First Submitted: December 12, 2007
First Posted: December 17, 2007
Last Update Posted: January 5, 2009
Last Verified: January 2009

Keywords provided by GAAD Medical Research Institute Inc.:
Fibroid Tumor
Fibroid Uterus
Fibroids, Uterine
Fibromyoma
Uterine Neoplasms

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases