NCT00574418

Brief Summary

A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 5, 2009

Status Verified

January 1, 2009

Enrollment Period

2.2 years

First QC Date

December 12, 2007

Last Update Submit

January 2, 2009

Conditions

Leiomyoma

Keywords

Fibroid TumorFibroid UterusFibroids, UterineFibromyomaUterine Neoplasms

Outcome Measures

Primary Outcomes (1)

  • The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids

    2 years and 9 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

1

OTHER
Radiation: Far Infrared Radiation (5μm to 20μm wavelength)

Interventions

Far Infrared Radiation (5μm to 20μm wavelength)RADIATION

Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.

Also known as: Far infrared radiation
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women age 18 or older with symptomatic fibroids

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre for Incurable Diseases

Toronto, Ontario, M4V 1L5, Canada

Location

MeSH Terms

Conditions

LeiomyomaUterine Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ken B Nedd, M.D.

    GAAD Medical Research Institute Inc.

    PRINCIPAL INVESTIGATOR

  • Kwasi Donyina, Ph.D.

    GAAD Medical Research Institute Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 17, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

September 1, 2008

Last Updated

January 5, 2009

Record last verified: 2009-01

Locations

CA(1)