Fibroid Ablation Study - Large Fibroids (FAST-L)

March 13, 2015 updated by: Gynesonics

Symptom Effectiveness Study of VizAblate® Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Large Uterine Fibroids

The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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
    • Noord-Brabant
      • Veldhoven, Noord-Brabant, Netherlands, 5500
        • Maxima Medisch Centrum
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1007
        • Vrije Universiteit Medisch Centrum
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7513 ER
        • Medisch Spectrum Twente
    • 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 Heath, 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
  • Consistent menstrual cycles
  • History of excessive bleeding for at least 3 months
  • Baseline UFS-QOL Symptom severity score ≥ 20
  • At least one target fibroid having a maximum diameter > 5cm and ≤ 10 cm
  • Not at material risk for pregnancy
  • Willingness to participate, adhere to follow-up requirements, and sign the informed consent form
  • Willing to have uniform maintenance of antifibrinolytic or non steroidal anti-inflammatory agents
  • Menstrual Pictogram score ≥ 120 during a one-month screening period.

Exclusion Criteria:

  • Presence of type 0 intracavitary fibroids
  • Target fibroid > 10cm in maximum diameter
  • Abnormality of the endometrial cavity that obstructs access of the treatment device
  • Postmenopausal
  • Desire for current or future fertility
  • Hemoglobin < 6 g/dl
  • Evidence of disorders of hemostasis
  • Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen, SERM or SPRM within the last 6 months prior to screening
  • Evidence for current cervical dysplasia (CIN II or greater)
  • Endometrial hyperplasia
  • Confirmed abdominal / pelvic malignancy within previous five years
  • Active pelvic infection or positive screen for pelvic gonorrhea or chlamydia
  • Clinically significant adenomyosis
  • Previous uterine artery embolization
  • Previous surgical or ablative treatment for fibroids or menorrhagia within 12 months prior to screening
  • Current use of anticoagulant therapy
  • Major medical or psychiatric illness affecting general health or ability to adhere to follow-up
  • Contraindication to MRI
  • Renal insufficiency
  • Uncontrolled hypertension lasting 2 years or more
  • Calcified fibroids
  • Presence of extrauterine pelvic mass
  • Presence of 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: VizAblate intervention
VizAblate System with subject serving 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: Baseline, 3 months, 12 months
Baseline, 3 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom and Quality-of-Life (UFS-QOL) Questionnaire
Time Frame: Baseline through 12 months
Baseline through 12 months
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
Percentage reduction in Menstrual Pictogram score
Time Frame: through 12 months
through 12 months

Collaborators and Investigators

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

Sponsor

Gynesonics

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

June 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (ESTIMATE)

February 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 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

  • CL 03536

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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