Fibroid Ablation Study

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
VizAblate treatment	VizAblate System	VizAblate System: subject acts as her own control

Primary Outcome Measures

Name	Time	Method
Mean percentage change in target fibroid perfused volume	3 months

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	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	baseline through 12 months
Percentage reduction in the Symptom Severity Subscale (SSS) of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire	baseline through 12 months
Return to normal daily activity	2 weeks or until returned to normal activity
Rate of surgical reintervention for menorrhagia	through 12 months

Locations (10): Vrije Universiteit Medisch Centrum
🇳🇱
Amsterdam, North Holland, Netherlands
Máxima Medisch Centrum
🇳🇱
Veldhoven, Noord-Brabant, Netherlands
Medisch Spectrum Twente
🇳🇱
Enschede, Netherlands
Birmingham Women's NHS Foundation Trust
🇬🇧
Birmingham, West Midlands, United Kingdom
Bradford Teaching Hospitals NHS Trust
🇬🇧
Bradford, West Yorkshire, United Kingdom
University College Hospital
🇬🇧
London, United Kingdom
Princess Royal Hospital
🇬🇧
Haywards Health, West Sussex, United Kingdom
Royal London Hospital
🇬🇧
Whitechapel, London, United Kingdom
Universidad Autonoma de Nuevo Leon (UANL)
🇲🇽
Monterrey, Nuevo Leon, Mexico
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Utrecht, Netherlands