Fibroid Ablation Study - Large Fibroids (FAST-L)
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ClinicalTrials.gov Identifier: NCT01539187 |
Recruitment Status
:
Terminated
(Investigational device changes)
First Posted
: February 27, 2012
Last Update Posted
: March 17, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leiomyoma Uterine Fibroids Menorrhagia | Device: VizAblate System | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
Experimental: VizAblate intervention
VizAblate System with subject serving as her own control
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Device: VizAblate System
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy
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- Mean percentage change in target fibroid perfused volume [ Time Frame: Baseline, 3 months, 12 months ]
- 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.
- 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 ]
- Rate of surgical reintervention for menorrhagia [ Time Frame: through 12 months ]
- Return to normal daily activity [ Time Frame: 2 weeks or until returned to normal activity ]
- Percentage reduction in Menstrual Pictogram score [ Time Frame: through 12 months ]

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Ages Eligible for Study: | 28 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539187
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 |
Study Director: | David Toub, MD | Gynesonics |
Responsible Party: | Gynesonics |
ClinicalTrials.gov Identifier: | NCT01539187 History of Changes |
Other Study ID Numbers: |
CL 03536 |
First Posted: | February 27, 2012 Key Record Dates |
Last Update Posted: | March 17, 2015 |
Last Verified: | March 2015 |
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 |