Study to Evaluate the Safety and Effectiveness of MRgFUS... | NCT01328067

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

NCT01328067

Sponsor

InSightec

Status

Withdrawn

Last Update Posted

Jun 15, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Uterine Fibroids
Bleeding
Pelvic Pain

Interventions

Exablate 2100
Myomectomy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Jan 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Mar 31, 2011

First Submission Date that Met QC Criteria

Apr 1, 2011

First Posted Date

Apr 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2018

Last Update Posted Date

Jun 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Active Comparator	MR guided Focused Ultrasound	Device: Exablate 2100
Surgery	Active Comparator	Myomectomy	Procedure: Myomectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exablate 2100	Device	MRgFUS	Treatment
Myomectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	36 months post treatment
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).	36 months post treatment

Secondary Outcomes

Measure	Description	Time Frame
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	36 months post treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007889	Leiomyoma
D006470	Hemorrhage
D017699	Pelvic Pain

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D013509	Gynecologic Surgical Procedures
D013519	Urogenital Surgical Procedures
D013514	Surgical Procedures, Operative