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OpenTrials
Completed

NCT Number: NCT00159328

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

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.

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Interventional Magnetic Resonance, St Mary's Hospital

London, W2 1NY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Guided Focused Ultrasound

Procedure

Primary outcomes

  1. Symptom improvement as judged by validated disease specific questionnaire

Secondary outcomes

  1. Change in fibroid and uterine volume.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • InSightec-TxSonics

Registry information

Official study title

Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids

Important dates

Study start
2003
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Aug 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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