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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:
Collaborator:
InSightec-TxSonics
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00159328
First received: September 9, 2005
Last updated: August 12, 2008
Last verified: August 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 9, 2005
Last Updated: August 12, 2008
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 16, 2013