Fibroid Ablation Study - Large Fibroids (FAST-L)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT01539187
First received: February 21, 2012
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Leiomyoma
Uterine Fibroids
Menorrhagia
Device: VizAblate System

Study Type: Interventional
Study Design: Endpoint Classification: 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 Large Uterine Fibroids

Further study details as provided by Gynesonics:

Primary Outcome Measures:
  • Mean percentage change in target fibroid perfused volume [ Time Frame: Baseline, 3 months, 12 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 Symptom Severity Score (SSS) subscale 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 ]
  • Percentage reduction in Menstrual Pictogram score [ Time Frame: through 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: June 2012
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 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

  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
  • 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
  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: NCT01539187

Locations
Mexico
Universidad Autonoma de Nuevo Leon (UANL)
Monterrey, Nuevo Leon, Mexico, 64460
Netherlands
Maxima Medisch Centrum
Veldhoven, Noord-Brabant, Netherlands, 5500
Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, Netherlands, 1007
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands, 7513 ER
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands, 3430
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 Heath, 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: NCT01539187     History of Changes
Other Study ID Numbers: CL 03536
Study First Received: February 21, 2012
Last Updated: November 22, 2013
Health Authority: United Kingdom: Research Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Mexico: Federal Commission for Protection Against Health Risks

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 August 21, 2014