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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00159328

Enrollment

Registered

2005-09-12

Start date

2003-03-31

Completion date

2006-12-31

Last updated

2008-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

Keywords

Magnetic Resonance Guided Focused Ultrasound, Gonadotrophin Releasing Hormone Agonist, 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.

Interventions

PROCEDUREMagnetic Resonance Guided Focused Ultrasound

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Symptom improvement as judged by validated disease specific questionnaire	—

Secondary

Measure	Time frame
Change in fibroid and uterine volume.	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026