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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

September 9, 2005
August 12, 2008
March 2003
Not Provided
Symptom improvement as judged by validated disease specific questionnaire
Same as current
Complete list of historical versions of study NCT00159328 on ClinicalTrials.gov Archive Site
Change in fibroid and uterine volume.
Same as current
Not Provided
Not Provided
 
Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids
Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine 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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Uterine Fibroids
Procedure: Magnetic Resonance Guided Focused Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2006
Not Provided

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00159328
UF008
Not Provided
Not Provided
Imperial College London
InSightec-TxSonics
Principal Investigator: wady m gedroyc St Mary's Hospital, Imperial College London.
Imperial College London
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP