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Fibroid Ablation Study (FAST-EU)
This study has been terminated.
(Investigational device changes; adequate enrollment achieved)
Sponsor:
Gynesonics
Information provided by (Responsible Party):
Gynesonics
ClinicalTrials.gov Identifier:
NCT01226290
First received: October 20, 2010
Last updated: March 13, 2015
Last verified: March 2015
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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: | 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 ]
Secondary Outcome Measures:
- 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 Menstrual Pictogram score [ Time Frame: 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 ]
- 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 ]
Other Outcome Measures:
- Subject satisfaction [ Time Frame: 3 month, 6 month, 12 months ]
- Anesthesia regimen [ Time Frame: Day of procedure ]
- System ease of use [ Time Frame: End of study ]
- Subject pain and tolerance of procedure [ Time Frame: Day of procedure ]
- HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire [ Time Frame: 3 month, 6 month, 12 months ]
- EuroQOL EQ-5D [ Time Frame: 3 month, 6 month, 12 month ]
- Length of Stay [ Time Frame: Day of procedure ]
- Nonsurgical reintervention for menorrhagia [ Time Frame: 30 day, 3 month, 6 month, 12 month ]
| Enrollment: | 51 |
| Study Start Date: | January 2011 |
| Study Completion Date: | March 2014 |
| Primary Completion Date: | March 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 (Adult, Senior) |
| Sexes 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
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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
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
| Responsible Party: | Gynesonics |
| ClinicalTrials.gov Identifier: | NCT01226290 History of Changes |
| Other Study ID Numbers: |
CL02413 |
| Study First Received: | October 20, 2010 |
| Last Updated: | March 13, 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 |
ClinicalTrials.gov processed this record on July 26, 2017