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Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159328
First Posted: September 12, 2005
Last Update Posted: August 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
InSightec-TxSonics
Information provided by:
Imperial College London
  Purpose
The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.

Condition Intervention Phase
Uterine Fibroids Procedure: Magnetic Resonance Guided Focused Ultrasound Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Symptom improvement as judged by validated disease specific questionnaire

Secondary Outcome Measures:
  • Change in fibroid and uterine volume.

Estimated Enrollment: 50
Study Start Date: March 2003
Estimated Study Completion Date: December 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject has given consent
  • Willing and able to attend all visits
  • Minimum age 18 with no desire for future fertility
  • Uterine fibroid > 300 cc on MRI
  • Normal cervical smear
  • Screening symptom score >21
  • Pre or peri-menopausal
  • Fibroids being device accessible

Exclusion Criteria:

  • Pregnancy
  • Previous GNRH treatment
  • HRT use
  • Hormonal Contraception
  • Patient on dialysis
  • Haematocrit <25
  • ASA score > 2
  • Severe cerebrovascular disease
  • Anticoagulated
  • Active pelvic infection or history of PID
  • Weight> 250 lbs
  • Any contra-indication to MR imaging
  • Intolerance to MRI contrast agent
  • Unable to remain in prone positions for 3hours
  • IUCD
  • Abdominal scarring in beam pathway
  • Breast feeding
  • Non-perfused fibroid on contrast enhanced images
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159328


Locations
United Kingdom
Department of Interventional Magnetic Resonance, St Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
InSightec-TxSonics
Investigators
Principal Investigator: wady m gedroyc St Mary's Hospital, Imperial College London.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00159328     History of Changes
Other Study ID Numbers: UF008
First Submitted: September 9, 2005
First Posted: September 12, 2005
Last Update Posted: August 13, 2008
Last Verified: August 2008

Keywords provided by Imperial College London:
Magnetic Resonance Guided Focused Ultrasound
Gonadotrophin Releasing Hormone Agonist
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