MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

NCT00295217 | Completed Phase 3

• 2 other identifiers: UF017Continued Access
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.

Conditions

Uterine Fibroids; Uterine Leiomyomas

Keywords

Fibroids; Uterine Leiomyomas; ExAblate; MrgFUS

Outcome Measures

Primary Outcomes (1)

• In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.

Interventions

ExAblate 2000 DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
• Able and willing to give consent and able 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 (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
• Fibroids(s) clearly visible on non-contrast MRI.

You may not qualify if:

• Metallic implants that are incompatible with MRI
• Sensitive to MRI contrast agents
• Severe claustrophobia that would prevent completion of procedure in MR unit
• Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
• Pedunculated fibroids
• Active pelvic inflammatory disease (PID)
• Active local or systemic infection
• Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
• Intrauterine device (IUD) anywhere in the treatment path
• Dermoid cyst of the ovary anywhere in the treatment path
• Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
• Undiagnosed vaginal bleeding

Sponsors & Collaborators

• InSightec: lead

Study Sites (4)

University of California at San Diego

La Jolla, California, 92037, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

KNI

Kalamazoo, Michigan, 49048, United States

Location

Cornell Vascular

New York, New York, 10022, United States

Location

Related Links

• Sponsor web page

MeSH Terms

Conditions

Leiomyoma; Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• George Holland, M.D.

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

• Mark Shaman, M.D.

  KNI

  PRINCIPAL INVESTIGATOR

• Robert Min, M.D.

  Cornell

  PRINCIPAL INVESTIGATOR

• Anne Roberts, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 23, 2006
• Study Start: February 1, 2006
• Study Completion: October 1, 2006
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

US (4)