The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.
Universidad Autonoma de Nuevo Leon (UANL)
Monterrey, Nuevo León, Mexico
Máxima Medisch Centrum
Veldhoven, North Brabant, Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, Netherlands
Mean percentage change in target fibroid perfused volume
Time frame: 3 months
Number of adverse events
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.
Time frame: procedure through 12 mo
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
University College Hospital
London, London, United Kingdom
Royal London Hospital
Whitechapel, London, United Kingdom
Birmingham Women's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Princess Royal Hospital
Haywards Health, West Sussex, United Kingdom
Bradford Teaching Hospitals NHS Trust
Bradford, West Yorkshire, United Kingdom