Fibroid Ablation Study (FAST-EU)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT01226290
First received: October 20, 2010
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.


Condition Intervention
Leiomyoma
Uterine Fibroids
Menorrhagia
Device: VizAblate System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids

Further study details as provided by Gynesonics:

Primary Outcome Measures:
  • Mean percentage change in target fibroid perfused volume [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: procedure through 12 mo ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rate of surgical reintervention for menorrhagia [ Time Frame: through 12 months ] [ Designated as safety issue: No ]
  • Return to normal daily activity [ Time Frame: 2 weeks or until returned to normal activity ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Subject satisfaction [ Time Frame: 3 month, 6 month, 12 months ] [ Designated as safety issue: No ]
  • Anesthesia regimen [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
  • System ease of use [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Subject pain and tolerance of procedure [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
  • HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire [ Time Frame: 3 month, 6 month, 12 months ] [ Designated as safety issue: No ]
  • EuroQOL EQ-5D [ Time Frame: 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]
  • Length of Stay [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
  • Nonsurgical reintervention for menorrhagia [ Time Frame: 30 day, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   28 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01226290

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

No publications provided

Responsible Party: Gynesonics
ClinicalTrials.gov Identifier: NCT01226290     History of Changes
Other Study ID Numbers: CL02413
Study First Received: October 20, 2010
Last Updated: July 16, 2014
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection
United Kingdom: Research Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Gynesonics:
uterine fibroid RF ablation
intrauterine ultrasound
VizAblate

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Menorrhagia
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014