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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

August 12, 2008

Start Date ^ICMJE

March 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Symptom improvement as judged by validated disease specific questionnaire

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00159328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in fibroid and uterine volume.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Uterine Fibroids

Intervention ^ICMJE

Procedure: Magnetic Resonance Guided Focused Ultrasound

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00159328

Other Study ID Numbers ^ICMJE

UF008

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

InSightec-TxSonics

Investigators ^ICMJE

Principal Investigator:

wady m gedroyc

St Mary's Hospital, Imperial College London.

Information Provided By

Imperial College London

Verification Date

August 2008

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

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