Far Infrared Radiation Treatment for Uterine Fibroids

January 2, 2009 updated by: GAAD Medical Research Institute Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4V 1L5
        • The Centre for Incurable Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Far infrared radiation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Two years and nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GAAD Medical Research Institute Inc.

Investigators

  • Principal Investigator: Ken B Nedd, M.D., GAAD Medical Research Institute Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

March 1, 2008

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 14, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 5, 2009

Last Update Submitted That Met QC Criteria

January 2, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAAD-UF-CTP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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