Clinical trial NCT00768742: Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Leiomyoma
Uterine Fibroids
Menorrhagia
Keywords: Uterine Fibroid RF Ablation
Intrauterine Ultrasound
VizAblate
Lead sponsor: Gynesonics
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* 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.

Primary outcomes:
measure: Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)
timeFrame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo
Secondary outcomes:
measure: Rate of surgical reintervention
timeFrame: 12 mo
measure: Quality of Life questionnaires
timeFrame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo
measure: Time required to return to normal daily activity
timeFrame: 7-14 days
measure: Adverse events
timeFrame: At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.
measure: Subject tolerance of procedure rated via analog visual scale
timeFrame: Discharge
measure: Fibroid dimension and non-perfused volume
timeFrame: Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo
measure: Pregnancy and pregnancy-related complications
timeFrame: 3 mo, 6 mo, 9 mo, and 12 mo
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Victoria General Hospital; Mature Women's Centre
state: Manitoba
city: Ottawa
country: Canada
facility: Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: Gynesonics
name: David Toub, M.D.
role: STUDY_DIRECTOR
References: