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
Recruitment status was Active, not recruiting
Sponsor:
GAAD Medical Research Institute Inc.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 16, 2013