Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Far Infrared Radiation
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Impotence, Male Impotence, Male Sexual Impotence
Eligibility Criteria
Inclusion Criteria:
- Persons with erection challenges
Exclusion Criteria:
- None
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 erectile dysfunction.
Secondary Outcome Measures
The effect of far infrared radiation on other male conditions like prostate cancer
Full Information
NCT ID
NCT00573209
First Posted
December 12, 2007
Last Updated
August 14, 2009
Sponsor
GAAD Medical Research Institute Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00573209
Brief Title
Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction
Official Title
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
May 2009 (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 possibility of using far infrared (FIR) radiation to treat impotency.
Detailed Description
Erectile dysfunction is characterized by the regular or repeated inability to obtain or maintain an erection. Erection depends on a complex interaction of psychological, neural, vascular and endocrine factors.
We are proposing a non-drug and a non-invasive radiation treatment for the enhancement of erection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Impotence, Male Impotence, Male Sexual Impotence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Far Infrared Radiation
Intervention Description
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.
Primary Outcome Measure Information:
Title
The primary end point is to determine the therapeutic effects of far infrared radiation on erectile dysfunction.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The effect of far infrared radiation on other male conditions like prostate cancer
Time Frame
1 year
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons with erection challenges
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Nedd, M.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kwasi Donyina, Ph.D.
Organizational Affiliation
GAAD Medical Research Institute Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
The Centre for Incurable Diseases
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5R 3G9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction
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