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

Uterine Fibroids Clinical Trial

— FAST  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00768742
• Other study ID #: CL00635
• Secondary ID: HC-126128
• Status: Withdrawn
• Phase: N/A
• First received: October 6, 2008
• Last updated: November 22, 2013
• Start date: September 2008
• Est. completion date: November 2010

Study information

• Verified date: November 2013
• Source: Gynesonics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Menorrhagia
• Uterine Fibroids

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital	Ottawa	Ontario
Canada	St. Joseph's Health Centre	Toronto	Ontario
Canada	Victoria General Hospital; Mature Women's Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Gynesonics

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC)		Baseline, 3 mo, 6 mo, 9 mo, 12 mo	No
Secondary	Rate of surgical reintervention		12 mo	No
Secondary	Quality of Life questionnaires		Baseline, 3 mo, 6 mo, 9 mo, 12 mo	No
Secondary	Time required to return to normal daily activity		7-14 days	No
Secondary	Adverse events		At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo.	Yes
Secondary	Subject tolerance of procedure rated via analog visual scale		Discharge	No
Secondary	Fibroid dimension and non-perfused volume		Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo	No
Secondary	Pregnancy and pregnancy-related complications		3 mo, 6 mo, 9 mo, and 12 mo	Yes