Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future

October 20, 2023 updated by: Imperial College London

Magnetic Resonance Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids in Women Desiring Future Pregnancies

The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Procedure: Magnetic Resonance Guided Focused Ultrasound

Study Type

Interventional

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - London, United Kingdom, W2 1NY
    - St Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

1. Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following criteria: Women 20-40 age. Women age < 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation.

If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test.

Women undergoing fertility treatment or plan to have sperm donation.

2. Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period.
3. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site.
4. Able and willing to give consent and able to attend all study visits
5. Able to communicate sensations during the MRgFUS procedure
6. Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
7. Tumor(s) are clearly visible on non-contrast MRI.
8. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH

Exclusion Criteria:

1. Patient is pregnant as confirmed by pregnancy test at time of screening
2. Uterine size >20 weeks as evaluated by US or MR.
3. Patients who are considered "high risk pregnancy" due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids.
4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable
5. Patients with adenomyosis
6. Patient is on dialysis
7. Hematocrit is < 25
8. Patient has hemolytic anemia
9. Patient has unstable cardiac status including: § Unstable angina pectoris on medication§ Documented myocardial infarction within 6 months of protocol entry§ Congestive heart failure requiring medication (other than diuretic)§ Currently taking anti-arrhythmic drugs§ Severe hypertension (diastolic BP>100 on medication)§ Presence of cardiac pacemaker
10. Patient has an ASA score of >2
11. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months)
12. Patient is on anti-coagulation therapy or has an underlying bleeding disorder
13. Evidence of uterine pathology other than leiomyoma
14. Patient has an active pelvic infection or history of pelvic inflammatory disease
15. Patient has an undiagnosed pelvic mass outside the uterus.
16. Patient weight >110 kg
17. Subject with extensive abdominal scarring in an area of the abdomen directly anterior to the treatment area.
18. Subject with standard contraindications for MR imaging such as non-MRI compatable implanted metallic devices.
19. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist).
20. Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hours.)
21. Patient with an intrauterine contraceptive device anywhere in the treatment beam path.
22. Women who are breast feeding.
23. Five or more fibroids, bigger then 3cm diameter, each

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pregnancy outcomes in women who have received treatment with MRgFUS

Secondary Outcome Measures

Outcome Measure
Efficacy of MRgFUS as judged by HRQOL questionnaires

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

InSightec

Investigators

Principal Investigator: Wady Gedroyc, St Mary's NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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. Erratum In: AJR Am J Roentgenol. 2005 Jan;184(1):348. Hynnen, Kullvro [corrected to Hynyen, Kullervo]; Macdanold, Nathan [corrected to Mcdannold, Nathan]; Kim, Kevin [corrected to Kim, Hyun S]; Gostout, Brian [corrected to Gostout, Bobbie].

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2004

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

UF004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.