Far Infrared Radiation Treatment for Uterine Fibroids | NCT00574418

Studies
Far Infrared Radiation Treatment for Uterine Fibroids

NCT00574418

Sponsor

GAAD Medical Research Institute Inc.

Status

Unknown status

Last Update Posted

Jan 5, 2009Estimated

Enrollment

2Actual

Phase

Phase 1

Conditions

Leiomyoma

Interventions

Far Infrared Radiation (5μm to 20μm wavelength)

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

Jan 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

Jan 2006

Primary Completion Date

Mar 2008Estimated

Completion Date

Sep 2008Estimated

First Submitted Date

Dec 12, 2007

First Submission Date that Met QC Criteria

Dec 14, 2007

First Posted Date

Dec 17, 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

Jan 2, 2009

Last Update Posted Date

Jan 5, 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 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.

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

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other		Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Far Infrared Radiation (5μm to 20μm wavelength)	Radiation	Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during 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 uterine fibroids		2 years and 9 months

Secondary Outcomes

Measure	Description	Time Frame
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.		Two years and nine months

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Centre for Incurable Diseases		Toronto	Ontario	M4V 1L5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma
D014594	Uterine Neoplasms

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided