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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean percentage change in target fibroid perfused volume
Time Frame: 3 months
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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