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

NCT ID: NCT00768742

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-11-30

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.

Conditions

Leiomyoma; Uterine Fibroids; Menorrhagia

Keywords

Uterine Fibroid RF Ablation; Intrauterine Ultrasound; VizAblate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

VizAblate Intrauterine Ultrasound-Guided RF Ablation

VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynesonics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Toub, M.D.

Role: STUDY_DIRECTOR

Gynesonics

Locations

Victoria General Hospital; Mature Women's Centre

Winnipeg, Manitoba, Canada

Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital

Ottawa, Ontario, Canada

St. Joseph's Health Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

HC-126128

Identifier Type: -

Identifier Source: secondary_id

CL00635

Identifier Type: -

Identifier Source: org_study_id