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

NCT ID: NCT00159328

Last Updated: 2008-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2006-12-31

Brief Summary

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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

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Conditions

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Uterine Fibroids

Keywords

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Magnetic Resonance Guided Focused Ultrasound Gonadotrophin Releasing Hormone Agonist Uterine Fibroids

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Magnetic Resonance Guided Focused Ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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InSightec-TxSonics

INDUSTRY

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Principal Investigators

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wady m gedroyc

Role: PRINCIPAL_INVESTIGATOR

St Mary's Hospital, Imperial College London.

Locations

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Department of Interventional Magnetic Resonance, St Mary's Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. doi: 10.2214/ajr.183.6.01831713.

Reference Type BACKGROUND
PMID: 15547216 (View on PubMed)

Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54. doi: 10.1067/mob.2003.345.

Reference Type BACKGROUND
PMID: 12861137 (View on PubMed)

Tempany CM, Stewart EA, McDannold N, Quade BJ, Jolesz FA, Hynynen K. MR imaging-guided focused ultrasound surgery of uterine leiomyomas: a feasibility study. Radiology. 2003 Mar;226(3):897-905. doi: 10.1148/radiol.2271020395.

Reference Type BACKGROUND
PMID: 12616023 (View on PubMed)

Other Identifiers

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UF008

Identifier Type: -

Identifier Source: org_study_id