Fibroid Ablation Study (FAST-EU)

March 13, 2015 updated by: Gynesonics

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Universidad Autonoma de Nuevo Leon (UANL)
  • Netherlands
      • Enschede, Netherlands, 7513 ER
        • Medisch Spectrum Twente
    • Noord-Brabant
      • Veldhoven, Noord-Brabant, Netherlands, 5500
        • Maxima Medisch Centrum
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1007
        • Vrije Universiteit Medisch Centrum
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3430
        • St. Antonius Ziekenhuis
  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University College Hospital
    • London
      • Whitechapel, London, United Kingdom, E1 1BB
        • Royal London Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TG
        • Birmingham Women's NHS Foundation Trust
    • West Sussex
      • Haywards Health, West Sussex, United Kingdom, RH16 3EJ
        • Princess Royal Hospital
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Bradford Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VizAblate treatment
VizAblate System: subject acts as her own control
Device: VizAblate System
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean percentage change in target fibroid perfused volume
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of surgical reintervention for menorrhagia
Time Frame: through 12 months
through 12 months
Return to normal daily activity
Time Frame: 2 weeks or until returned to normal activity
2 weeks or until returned to normal activity
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.
procedure through 12 mo
Percentage reduction in Menstrual Pictogram score
Time Frame: baseline through 12 months
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
baseline through 12 months

Other Outcome Measures

Outcome Measure
Time Frame
Subject satisfaction
Time Frame: 3 month, 6 month, 12 months
3 month, 6 month, 12 months
Anesthesia regimen
Time Frame: Day of procedure
Day of procedure
System ease of use
Time Frame: End of study
End of study
Subject pain and tolerance of procedure
Time Frame: Day of procedure
Day of procedure
HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire
Time Frame: 3 month, 6 month, 12 months
3 month, 6 month, 12 months
EuroQOL EQ-5D
Time Frame: 3 month, 6 month, 12 month
3 month, 6 month, 12 month
Length of Stay
Time Frame: Day of procedure
Day of procedure
Nonsurgical reintervention for menorrhagia
Time Frame: 30 day, 3 month, 6 month, 12 month
30 day, 3 month, 6 month, 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynesonics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

April 2, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL02413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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