Therapeutic MRI Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids (HIFU)
This study has been completed.
Sponsor:
Philips Healthcare
Information provided by (Responsible Party):
Philips Healthcare
ClinicalTrials.gov Identifier:
NCT01141062
First received: June 8, 2010
Last updated: December 3, 2012
Last verified: December 2012
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Purpose
This study is to collect supplementary safety and technical effectiveness data of Philips MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic fibroids in a 3T MRI scanner. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women. MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to collect supplementary 3T treatment safety and technical effectiveness data in a 1 month follow-up study. MRguided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Leiomyomas |
Device: Philips MR-guided HIFU |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Therapeutic MRI Guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids |
Further study details as provided by Philips Healthcare:
Primary Outcome Measures:
- Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting. [ Time Frame: Day of treatment, 24, 48, 72 hrs, 1 and 2 wks and 30 days after treatment ] [ Designated as safety issue: Yes ]Safety of HIFU for treatment of the uterine fibroids as determined by adverse event reporting.
- Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score [ Time Frame: Day of treatment, 30 days after treatment ] [ Designated as safety issue: No ]Technical efficacy of HIFU for treatment of uterine fibroids as assessed by a change in the Symptom Severity Score
Secondary Outcome Measures:
- Change in Quality of Life Scores [ Time Frame: 0, 30 days ] [ Designated as safety issue: No ]Change in Quality of Life Scores
- Pain score [ Time Frame: 0, 24, 48, 72 hours and 1 and 2 weeks, and 30 days ] [ Designated as safety issue: No ]Pain scores before, during and after treatment: This endpoints will be recorded using a 10-point visual analog scale for pain 4-point scale for discomfort.
- Timeframe before returning to daily activities [ Time Frame: 0, 24, 48, 72 hours and 1 and 2 weeks, and 30 days ] [ Designated as safety issue: No ]Timeframe before returning to daily activities
| Enrollment: | 15 |
| Study Start Date: | June 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treated leiomyomas
Philips MR-guided HIFU
|
Device: Philips MR-guided HIFU
HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 59 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women, age between 18 and 59 years
- Weight < 140kg
- Pre- or peri-menopausal
- Uterine size < 24 weeks
- Transformed SSS score > 40
- Normal Cervical cell assessment by PAP
- Symptomatic Fibroid disease
- Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm
Exclusion Criteria:
- Other Pelvic Disease
- Desire for future pregnancy
- Significant systemic disease even if controlled
- Positive pregnancy test
- Hematocrit < 25%
- Scarring or other interference of the HIFU beam
- MRI or contrast contraindicated
- Fibroids not quantifiable on MRI
- Calcifications around or throughout uterine tissues
- Communication barrier
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141062
Locations
| Canada, Ontario | |
| Thunder Bay Regional Health Sciences Centre | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Sunnybrook Health Sciences Centre, University of Toronto | |
| Toronto, Ontario, Canada, M4N 3M5 | |
Sponsors and Collaborators
Philips Healthcare
Investigators
| Principal Investigator: | Elizabeth David, MD | Sunnybrook Health Sciences Centre |
| Principal Investigator: | Neety Panu, MD | Thunder Bay Regional Health Sciences Centre |
More Information
Publications:
| Responsible Party: | Philips Healthcare |
| ClinicalTrials.gov Identifier: | NCT01141062 History of Changes |
| Other Study ID Numbers: | 998933A |
| Study First Received: | June 8, 2010 |
| Last Updated: | December 3, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Philips Healthcare:
|
Uterine Fibroids |
Additional relevant MeSH terms:
|
Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 21, 2013