Fibroid Ablation Study (FAST-EU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01226290
Recruitment Status : Terminated (Investigational device changes; adequate enrollment achieved)
First Posted : October 22, 2010
Last Update Posted : April 2, 2015
Information provided by (Responsible Party):

October 20, 2010
October 22, 2010
April 2, 2015
January 2011
March 2014   (Final data collection date for primary outcome measure)
Mean percentage change in target fibroid perfused volume [ Time Frame: 3 months ]
Mean percentage change in target fibroid perfused volume [ Time Frame: Baseline, at procedure, 3 months ]
Complete list of historical versions of study NCT01226290 on Archive Site
  • Number of adverse events [ Time Frame: procedure through 12 mo ]
    Procedure safety will be assessed by recording all adverse events that occur on the day of the procedure. Longer-term safety will be assessed by recording at each follow-up visit any untoward medical occurrence since baseline. Each adverse event will be assessed for severity and relationship to study device.
  • Percentage reduction in Menstrual Pictogram score [ Time Frame: baseline through 12 months ]
  • Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire [ Time Frame: baseline through 12 months ]
  • Rate of surgical reintervention for menorrhagia [ Time Frame: through 12 months ]
  • Return to normal daily activity [ Time Frame: 2 weeks or until returned to normal activity ]
Same as current
  • Subject satisfaction [ Time Frame: 3 month, 6 month, 12 months ]
  • Anesthesia regimen [ Time Frame: Day of procedure ]
  • System ease of use [ Time Frame: End of study ]
  • Subject pain and tolerance of procedure [ Time Frame: Day of procedure ]
  • HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire [ Time Frame: 3 month, 6 month, 12 months ]
  • EuroQOL EQ-5D [ Time Frame: 3 month, 6 month, 12 month ]
  • Length of Stay [ Time Frame: Day of procedure ]
  • Nonsurgical reintervention for menorrhagia [ Time Frame: 30 day, 3 month, 6 month, 12 month ]
Not Provided
Fibroid Ablation Study
Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids
The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
Not Provided
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leiomyoma
  • Uterine Fibroids
  • Menorrhagia
Device: VizAblate System
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.
Experimental: VizAblate treatment
VizAblate System: subject acts as her own control
Intervention: Device: VizAblate System
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 28 years of age or older
  • Regular, consistent menstrual cycles
  • History of excessive bleeding
  • One Menstrual Pictogram score ≥ 120 during a one-month screening period
  • Baseline Uterine Fibroid Symptom & Quality of Life (UFS-QOL) Symptom Severity Subscale (SSS) score ≥ 20
  • Between 1 and 5 Target Fibroids between 1 cm and 5 cm and/or maximum volume 82.4cc
  • At least one fibroid must indent the endometrium
  • Subject is not at material risk for pregnancy.
  • Subject is willing to maintain use or non-use of hormonal contraception
  • Subject is willing to have uniform maintenance (use or non-use) of any antifibrinolytic or nonsteroidal anti-inflammatory agents

Exclusion Criteria:

  • Subserosal fibroids with bulk symptoms
  • Presence of type 0 intracavitary fibroids
  • Any Target Fibroid > 5 cm in maximum diameter with a volume > 82.4cc
  • Any fibroid that obstructs access of the VizAblate probe
  • Postmenopausal by history
  • Desire for current or future fertility
  • Hemoglobin < 6 g/dl
  • Pregnancy
  • Evidence of disorders of hemostasis
  • Use of Gonadotropin-releasing hormone (GnRH) agonist or implantable or injectable progestin and/or estrogen, Selective Estrogen Receptor Modulators (SERM) or selective progesterone receptor modulator (SPRM)
  • Short-term use of hormonal medication for management of bleeding
  • Evidence for current cervical dysplasia
  • Endometrial hyperplasia
  • Confirmed abdominal / pelvic malignancy within the previous five years
  • Active pelvic infection
  • Clinically significant adenomyosis
  • Previous uterine artery embolization. Previous surgical or ablative treatment for fibroids or menorrhagia within previous 12 months
  • Current use of anticoagulant therapy
  • Need for emergency surgery to treat fibroid symptoms
  • Concomitant intrauterine polyps > 1.0 cm
  • Contraindication to MRI
  • Renal insufficiency
  • Uncontrolled hypertension lasting 2 years or more
  • One or more treatable fibroids that are calcified
  • Chronic pelvic pain
  • Presence of an extrauterine pelvic mass
  • Presence of a tubal implant for sterilization
  • Previous pelvic irradiation
  • Endometrial cavity length < 4.5 cm
Sexes Eligible for Study: Female
28 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Mexico,   Netherlands,   United Kingdom
Not Provided
Not Provided
Not Provided
Study Director: David Toub, MD Gynesonics
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP