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

This study has been withdrawn prior to enrollment.

(study revised and reinitiated under another protocol)

Sponsor:

Information provided by (Responsible Party):

Gynesonics

ClinicalTrials.gov Identifier:

NCT00768742

First received: October 6, 2008

Last updated: November 22, 2013

Last verified: November 2013

History of Changes

Purpose

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	Intervention
Leiomyoma Uterine Fibroids Menorrhagia	Device: VizAblate Intrauterine Ultrasound-Guided RF Ablation


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Bleeding Menstruation Ultrasound

U.S. FDA Resources

Further study details as provided by Gynesonics:

Primary Outcome Measures:

Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Rate of surgical reintervention [ Time Frame: 12 mo ] [ Designated as safety issue: No ]
Quality of Life questionnaires [ Time Frame: Baseline, 3 mo, 6 mo, 9 mo, 12 mo ] [ Designated as safety issue: No ]
Time required to return to normal daily activity [ Time Frame: 7-14 days ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo. ] [ Designated as safety issue: Yes ]
Subject tolerance of procedure rated via analog visual scale [ Time Frame: Discharge ] [ Designated as safety issue: No ]
Fibroid dimension and non-perfused volume [ Time Frame: Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo ] [ Designated as safety issue: No ]
Pregnancy and pregnancy-related complications [ Time Frame: 3 mo, 6 mo, 9 mo, and 12 mo ] [ Designated as safety issue: Yes ]


Enrollment:	0
Study Start Date:	September 2008
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility


Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768742

Locations


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

Sponsors and Collaborators

Gynesonics

Investigators


Study Director:	David Toub, M.D.	Gynesonics

More Information

No publications provided


Responsible Party:	Gynesonics
ClinicalTrials.gov Identifier:	NCT00768742 History of Changes
Other Study ID Numbers:	CL00635, HC-126128
Study First Received:	October 6, 2008
Last Updated:	November 22, 2013
Health Authority:	Canada: Health Canada

Keywords provided by Gynesonics:


Uterine Fibroid RF Ablation Intrauterine Ultrasound VizAblate

Additional relevant MeSH terms:


Leiomyoma Myofibroma Connective Tissue Diseases Neoplasms	Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

ClinicalTrials.gov processed this record on March 03, 2015

To Top