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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00295217
Other study ID # UF017
Secondary ID Continued Access
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2006
Est. completion date October 2006

Study information

Verified date December 2018
Source InSightec
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.

2. Able and willing to give consent and able to attend all study visits.

3. Patient is pre or peri-menopausal (within 12 months of last menstrual period).

4. Able to communicate sensations during the ExAblate procedure.

5. 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).

6. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

1. Metallic implants that are incompatible with MRI

2. Sensitive to MRI contrast agents

3. Severe claustrophobia that would prevent completion of procedure in MR unit

4. Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.

5. Pedunculated fibroids

6. Active pelvic inflammatory disease (PID)

7. Active local or systemic infection

8. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia

9. Intrauterine device (IUD) anywhere in the treatment path

10. Dermoid cyst of the ovary anywhere in the treatment path

11. Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)

12. Undiagnosed vaginal bleeding

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ExAblate 2000


Locations

Country Name City State
United States Lahey Clinic Burlington Massachusetts
United States KNI Kalamazoo Michigan
United States University of California at San Diego La Jolla California
United States Cornell Vascular New York New York

Sponsors (1)

Lead Sponsor Collaborator
InSightec

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
See also
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Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A

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