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

NCT01328067 | Withdrawn

• 1 other identifier: UF034
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Fibroids; Bleeding; Pelvic Pain

Keywords

MRgFus; Uterine Fibroids; Pelvic Pain; Quality of Life; Symptomatic Uterine Fibroids

Outcome Measures

Primary Outcomes (2)

• 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 (1)

• Efficacy

  36 months post treatment

Study Arms (2)

Treatment

ACTIVE COMPARATOR

MR guided Focused Ultrasound

Device: Exablate 2100

Surgery

ACTIVE COMPARATOR

Myomectomy

Procedure: Myomectomy

Interventions

Exablate 2100 DEVICE

MRgFUS

Treatment

Myomectomy PROCEDURE

Non-Hysteroscopic Myomectomy

Surgery

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Links

• Sponsor's website

MeSH Terms

Conditions

Leiomyoma; Hemorrhage; Pelvic Pain

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Wady Gedroyc, Prof.

  St Mary's Hospital, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 4, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

GB (1)