Fibroid Ablation Study (FAST-EU)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Leiomyoma; Uterine Fibroids; Menorrhagia	Device: VizAblate System	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	51 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 Uterine Fibroids
Study Start Date :	January 2011
Actual Primary Completion Date :	March 2014
Actual Study Completion Date :	March 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Mean percentage change in target fibroid perfused volume [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. 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.
2. Percentage reduction in Menstrual Pictogram score [ Time Frame: baseline through 12 months ]
3. 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 ]
4. Rate of surgical reintervention for menorrhagia [ Time Frame: through 12 months ]
5. Return to normal daily activity [ Time Frame: 2 weeks or until returned to normal activity ]

Other Outcome Measures:

1. Subject satisfaction [ Time Frame: 3 month, 6 month, 12 months ]
2. Anesthesia regimen [ Time Frame: Day of procedure ]
3. System ease of use [ Time Frame: End of study ]
4. Subject pain and tolerance of procedure [ Time Frame: Day of procedure ]
5. HRQL sub scale of Uterine Fibroid Symptom Quality of Life (UFS-QOL) questionnaire [ Time Frame: 3 month, 6 month, 12 months ]
6. EuroQOL EQ-5D [ Time Frame: 3 month, 6 month, 12 month ]
7. Length of Stay [ Time Frame: Day of procedure ]
8. Nonsurgical reintervention for menorrhagia [ Time Frame: 30 day, 3 month, 6 month, 12 month ]

Eligibility Criteria

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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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Gynesonics
ClinicalTrials.gov Identifier:	NCT01226290 History of Changes
Other Study ID Numbers:	CL02413
First Posted:	October 22, 2010
Last Update Posted:	April 2, 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