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Far Infrared Radiation Treatment for Uterine Fibroids

Primary Purpose

Leiomyoma

Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Far Infrared Radiation (5μm to 20μm wavelength)
Sponsored by
GAAD Medical Research Institute Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma focused on measuring Fibroid Tumor, Fibroid Uterus, Fibroids, Uterine, Fibromyoma, Uterine Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • The Centre for Incurable Diseases

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids

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.

Full Information

First Posted
December 12, 2007
Last Updated
January 2, 2009
Sponsor
GAAD Medical Research Institute Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00574418
Brief Title
Far Infrared Radiation Treatment for Uterine Fibroids
Official Title
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2008 (Anticipated)
Study Completion Date
September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
GAAD Medical Research Institute Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma
Keywords
Fibroid Tumor, Fibroid Uterus, Fibroids, Uterine, Fibromyoma, Uterine Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Far Infrared Radiation (5μm to 20μm wavelength)
Other Intervention Name(s)
Far infrared radiation
Intervention Description
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken B Nedd, M.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwasi Donyina, Ph.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The Centre for Incurable Diseases
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4V 1L5
Country
Canada

12. IPD Sharing Statement

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Far Infrared Radiation Treatment for Uterine Fibroids

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