search
Back to results

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

Primary Purpose

Uterine Fibroids, Bleeding, Pelvic Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exablate 2100
Myomectomy
Sponsored by
InSightec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring MRgFus, Uterine Fibroids, Pelvic Pain, Quality of Life, Symptomatic Uterine Fibroids

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment

Surgery

Arm Description

MR guided Focused Ultrasound

Myomectomy

Outcomes

Primary Outcome Measures

Safety
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.
Efficacy
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).

Secondary Outcome Measures

Efficacy
Post treatment change in patient's quality of life Post treatment change in pelvic pain Post treatment Change in bleeding Post treatment recovery time

Full Information

First Posted
March 31, 2011
Last Updated
June 13, 2018
Sponsor
InSightec
search

1. Study Identification

Unique Protocol Identification Number
NCT01328067
Brief Title
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
Official Title
A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Withdrawn
Study Start Date
June 2011 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Bleeding, Pelvic Pain
Keywords
MRgFus, Uterine Fibroids, Pelvic Pain, Quality of Life, Symptomatic Uterine Fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
MR guided Focused Ultrasound
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Myomectomy
Intervention Type
Device
Intervention Name(s)
Exablate 2100
Intervention Description
MRgFUS
Intervention Type
Procedure
Intervention Name(s)
Myomectomy
Intervention Description
Non-Hysteroscopic Myomectomy
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
36 months post treatment
Title
Efficacy
Description
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).
Time Frame
36 months post treatment
Secondary Outcome Measure Information:
Title
Efficacy
Description
Post treatment change in patient's quality of life Post treatment change in pelvic pain Post treatment Change in bleeding Post treatment recovery time
Time Frame
36 months post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women age 18 or older 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). Women who have given written informed consent Women who are able and willing to attend all study visits Patient is pre or peri-menopausal (within 12 months of last menstrual period) Able to communicate sensations during the ExAblate procedure Uterine fibroids, which are device accessible Fibroid(s) clearly visible on non-contrast MRI. Fibroid(s) enhances on MR contrast imaging Exclusion Criteria: Women currently pregnant Uterine size > 24 cm W/O the cervix More than 4 clinically significant fibroids (per MRI) Prior myomectomy, UAE Allergy to either gadolinium or iodinated contrast Implanted metallic device prohibiting MRI Severe claustrophobia Active pelvic infection Current use of intrauterine contraceptive device Unstable medical conditions requiring additional monitoring during the procedure Bleeding diathesis requiring medical treatment Imaging suggestive of malignant disease of uterus, ovary, or cervix Imaging and suggestive of adenomyosis. Pedunculated submucosal or pedunculated subserosal myoma Size and weight which prohibits subject from fitting in MRI device Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical clips or hard implants in the beam path. Hyper intense fibroid relatively to the uterus muscle Women with ovarian dermoid cyst anywhere in the treatment path
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wady Gedroyc, Prof.
Organizational Affiliation
St Mary's Hospital, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.insightec.com
Description
Sponsor's website

Learn more about this trial

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

We'll reach out to this number within 24 hrs