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

Gynesonics

Status: Withdrawn

Conditions: Uterine Fibroids; Leiomyoma; Menorrhagia

Treatments: Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00768742

HC-126128

CL00635

Details and patient eligibility

About

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.

Sex: Female

Ages: 25+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)