Far Infrared Radiation Treatment for Uterine Fibroids

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by GAAD Medical Research Institute Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
GAAD Medical Research Institute Inc.
ClinicalTrials.gov Identifier:
NCT00574418
First received: December 12, 2007
Last updated: January 2, 2009
Last verified: January 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 12, 2007
Last Updated: January 2, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on July 23, 2014