FAST: Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study

Sponsor

Gynesonics (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00768742

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leiomyoma Uterine Fibroids Menorrhagia	Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) [Baseline, 3 mo, 6 mo, 9 mo, 12 mo]

Secondary Outcome Measures

Rate of surgical reintervention [12 mo]
Quality of Life questionnaires [Baseline, 3 mo, 6 mo, 9 mo, 12 mo]
Time required to return to normal daily activity [7-14 days]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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
Willing to sign a consent form

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
Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease)
Adenomyosis
Previous surgical or ablative treatment for fibroids or menorrhagia
Previous uterine artery embolization or occlusion
Patient on anti-coagulation therapy
Needing emergency surgery to treat fibroid symptoms
Concomitant intrauterine polyps.
Major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data
Contraindication to MRI
Allergy to contrast media
Mild renal insufficiency or worse
Known renal disease
Uncontrolled hypertension lasting 2 years or more
Diabetes
Uterine size > 10 weeks or 10 cm from ectocervix to fundus.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Victoria General Hospital; Mature Women's Centre	Winnipeg	Manitoba	Canada	R3T 2A8
2	Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 7W9
3	St. Joseph's Health Centre	Toronto	Ontario	Canada	M6R 1B5