Erectile DysfunctionPhase 1NCT00573209
Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction
A Phase 1 study testing Far Infrared Radiation in people with Erectile Dysfunction, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
Trial summary
A preliminary study to determine the possibility of using far infrared (FIR) radiation to treat impotency. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Far Infrared Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons with erection challenges
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction.
A preliminary study to determine the possibility of using far infrared (FIR) radiation to treat impotency.
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Far Infrared Radiation
- Keywords
- Impotence, Male Impotence, Male Sexual Impotence
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far Infrared RadiationRadiation
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Radiation: Far Infrared Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is to determine the therapeutic effects of far infrared radiation on erectile dysfunction.
Measured: 1 year
Secondary outcomes (1)
The effect of far infrared radiation on other male conditions like prostate cancer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2009
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GAAD Medical Research Institute Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Ken Nedd, M.D., Study director, GAAD Medical Research Institute Inc.Kwasi Donyina, Ph.D., Study chair, GAAD Medical Research Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573209
- Sponsor's protocol ID
- GAAD-EDS-CTP1
- Status last verified
- Aug 2009
- First submitted
- 12 Dec 2007
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT00573209
- Acronym / sponsor ID
- GAAD-EDS-CTP1
- Conditions
- Erectile Dysfunction
- Keywords
- Impotence, Male Impotence, Male Sexual Impotence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GAAD Medical Research Institute Inc.University, hospital or other
- Study start
- Aug 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (estimated)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: Far Infrared Radiation |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Persons with erection challenges
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far Infrared RadiationFar Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session. | Radiation | 1 |
Primary outcome
The primary end point is to determine the therapeutic effects of far infrared radiation on erectile dysfunction.
Time frame: 1 year
1 secondary outcome
The effect of far infrared radiation on other male conditions like prostate cancer
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2009.
Related trials for Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Recruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
Recruiting
Embolosclerotherapy Versus Deep Dorsal Vein Revascularization in Venogenic Erectile Dysfunction
Erectile Dysfunction Due to Venous Disorder, Erectile Dysfunction (ED)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Nedd, M.D. study director
GAAD Medical Research Institute Inc.
Kwasi Donyina, Ph.D. study chair
GAAD Medical Research Institute Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Far Infrared Radiation in people with Erectile Dysfunction, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point is to determine the therapeutic effects of far infrared radiation on erectile dysfunction. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2009.