Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores

Gynesonics3 sites in 1 countrySeptember 2008

ConditionsLeiomyoma Uterine Fibroids Menorrhagia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Leiomyoma
Sponsor: Gynesonics
Locations: 3
Primary Endpoint: Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

November 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Gynesonics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pre-menopausal
•Regular, consistent menstrual cycles
•Serum progesterone \> 6 ng/ml (19 nmol/L)
•2 months history of PBLAC score of 150-500
•Maximum of 4 type I, type II, or intramural fibroids
•Patient is at low risk for cervical cancer
•Hemoglobin \> 6 g/dl
•Not at risk for pregnancy
•No desire for future fertility
•Willing and able to complete the follow-up requirements outlined in the study design section of the protocol

Exclusion Criteria

•Subserosal fibroids.
•Any fibroid that obstructs access to the endometrial cavity
•FSH \> 20 IU/L
•Pregnancy
•Evidence of disorders of hemostasis
•Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen
•SERMS/SPRMS within the last 6 months
•Current use of any IUD or use of Mirena IUS within the last 3 months
•Gynecological malignancy or hyperplasia
•Known/suspected abdominal/pelvic cancer

Outcomes

Primary Outcomes

Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)

Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo

Secondary Outcomes

Quality of Life questionnaires(Baseline, 3 mo, 6 mo, 9 mo, 12 mo)
Rate of surgical reintervention(12 mo)
Adverse events(At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.)
Subject tolerance of procedure rated via analog visual scale(Discharge)
Fibroid dimension and non-perfused volume(Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo)
Pregnancy and pregnancy-related complications(3 mo, 6 mo, 9 mo, and 12 mo)
Time required to return to normal daily activity(7-14 days)