Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids

June 13, 2018 updated by: InSightec

A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids

The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.

Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.

All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.

Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women age 18 or older
  2. Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 (raw score) of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL).
  3. Women who have given written informed consent
  4. Women who are able and willing to attend all study visits
  5. Patient is pre or peri-menopausal (within 12 months of last menstrual period)
  6. Able to communicate sensations during the ExAblate procedure
  7. Uterine fibroids, which are device accessible
  8. Fibroid(s) clearly visible on non-contrast MRI.
  9. Fibroid(s) enhances on MR contrast imaging

Exclusion Criteria:

  1. Women currently pregnant
  2. Uterine size > 24 cm W/O the cervix
  3. More than 4 clinically significant fibroids (per MRI)
  4. Prior myomectomy, UAE
  5. Allergy to either gadolinium or iodinated contrast
  6. Implanted metallic device prohibiting MRI
  7. Severe claustrophobia
  8. Active pelvic infection
  9. Current use of intrauterine contraceptive device
  10. Unstable medical conditions requiring additional monitoring during the procedure
  11. Bleeding diathesis requiring medical treatment
  12. Imaging suggestive of malignant disease of uterus, ovary, or cervix
  13. Imaging and suggestive of adenomyosis.
  14. Pedunculated submucosal or pedunculated subserosal myoma
  15. Size and weight which prohibits subject from fitting in MRI device
  16. Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical clips or hard implants in the beam path.
  17. Hyper intense fibroid relatively to the uterus muscle
  18. Women with ovarian dermoid cyst anywhere in the treatment path

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
MR guided Focused Ultrasound
Device: Exablate 2100
MRgFUS
Active Comparator: Surgery
Myomectomy
Procedure: Myomectomy
Non-Hysteroscopic Myomectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 36 months post treatment
Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.
36 months post treatment
Efficacy
Time Frame: 36 months post treatment
Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years).
36 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 36 months post treatment
  1. Post treatment change in patient's quality of life
  2. Post treatment change in pelvic pain
  3. Post treatment Change in bleeding
  4. Post treatment recovery time
36 months post treatment

Collaborators and Investigators

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

Sponsor

InSightec

Investigators

  • Principal Investigator: Wady Gedroyc, Prof., St Mary's Hospital, London

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.

Helpful Links

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

June 1, 2011

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

March 31, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (Estimate)

April 4, 2011

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF034

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.

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