LeiomyomaPhase 1NCT00574418
Far Infrared Radiation Treatment for Uterine Fibroids
A Phase 1 study testing Far Infrared Radiation (5μm to 20μm wavelength) in people with Leiomyoma, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
Trial summary
A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Far Infrared Radiation (5μm to 20μm wavelength)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Sep 2008
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age 18 or older with symptomatic fibroids
Who cannot join
- 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)
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 Uterine Fibroids
A preliminary study to determine the efficacy of using energy specific far infrared (FIR) radiation for the treatment of uterine fibroids.
Read the 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.
- Conditions
- Leiomyoma
- Being tested
- Far Infrared Radiation (5μm to 20μm wavelength)
- Keywords
- Fibroid Tumor, Fibroid Uterus, Fibroids, Uterine, Fibromyoma, Uterine Neoplasms
- Medical subject headings
- Leiomyoma, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far Infrared Radiation (5μm to 20μm wavelength)Radiation
Also called Far infrared radiation
Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Radiation: Far Infrared Radiation (5μm to 20μm wavelength) |
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 uterine fibroids
Measured: 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.
Measured: Two years and nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionMar 2008 (estimated)
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- GAAD Medical Research Institute Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Ken B Nedd, M.D., Principal investigator, GAAD Medical Research Institute Inc.Kwasi Donyina, Ph.D., Study director, GAAD Medical Research Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574418
- Sponsor's protocol ID
- GAAD-UF-CTP1
- Status last verified
- Jan 2009
- First submitted
- 12 Dec 2007
- Last updated
- 5 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 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 Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00574418
- Acronym / sponsor ID
- GAAD-UF-CTP1
- Conditions
- Leiomyoma
- Keywords
- Fibroid Tumor, Fibroid Uterus, Fibroids, Uterine, Fibromyoma, Uterine Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- GAAD Medical Research Institute Inc.University, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 17 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 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.
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 (5μm to 20μm wavelength) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women age 18 or older with symptomatic fibroids
Key exclusion criteria (3 listed)
- 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)
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 Radiation (5μm to 20μm wavelength)Also: Far infrared radiationFar Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes during each session. | Radiation | 1 |
Primary outcome
The primary end point is to determine the therapeutic effects of far infrared radiation on uterine fibroids
Time frame: 2 years and 9 months
1 secondary outcome
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.
Time frame: Two years and nine months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2009.
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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 B Nedd, M.D. principal investigator
GAAD Medical Research Institute Inc.
Kwasi Donyina, Ph.D. study director
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 (5μm to 20μm wavelength) in people with Leiomyoma, 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 3 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 5 Jan 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 uterine fibroids (time frame: 2 years and 9 months). 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 5 Jan 2009.