Energy Specific Far Infrared Radiation Treatment for Erec... | NCT00573209

Studies
Energy Specific Far Infrared Radiation Treatment for Erectile Dysfunction

NCT00573209

Sponsor

GAAD Medical Research Institute Inc.

Status

Unknown status

Last Update Posted

Aug 17, 2009Estimated

Enrollment

3Actual

Phase

Phase 1

Conditions

Erectile Dysfunction

Interventions

Far Infrared Radiation

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Feb 2009Actual

Completion Date

May 2009Estimated

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 12, 2007

First Posted Date

Dec 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2009

Last Update Posted Date

Aug 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other		Radiation: Far Infrared Radiation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Far Infrared Radiation	Radiation	Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each session.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary end point is to determine the therapeutic effects of far infrared radiation on erectile dysfunction.		1 year

Secondary Outcomes

Measure	Description	Time Frame
The effect of far infrared radiation on other male conditions like prostate cancer		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons with erection challenges

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ken Nedd, M.D.	GAAD Medical Research Institute Inc.	Study Director
Kwasi Donyina, Ph.D.	GAAD Medical Research Institute Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Centre for Incurable Diseases		Mississauga	Ontario	L5R 3G9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007172	Erectile Dysfunction

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

Browse Leaves

Not provided

Browse Branches

Not provided