Uterine Fibroids Clinical Trial
Official title:
Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation
Study is intended to evaluate the one-year safety and clinical status of patients treated
for symptomatic uterine fibroids with the VizAblate Intrauterine-ultrasound guided radio
frequency (RF) ablation system. Particular attention will be directed to recording safety
outcomes including incidence of uterine cavity synechiae. In addition, information on
quality of life will be collected.
Overall study duration (first patient enrolled through last patient exit) will be comprised
of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment,
and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an
individual patient, once enrolled, will be approximately 1 month for baseline observations
and treatment scheduling, and 12 months for follow up after treatment for a total duration
of approximately 13 months.
In this single-arm study, subjects who receive transcervical intrauterine-ultrasound guided
RF ablation of symptomatic uterine fibroids with the VizAblate® System will be assessed with
3D pelvic sonography with contrast, hysteroscopy, and quality of life questionnaires.
Overall study duration (first patient enrolled through last patient exit) will be comprised
of approximately 12 months of patient enrollment up to 1 month for scheduling of treatment,
and 12 months of follow-up, for a total duration of up to 25 months. Study duration for an
individual patient, once enrolled, will be approximately 1 month for baseline observations
and treatment scheduling, and 12 months for follow up after treatment for a total duration
of approximately 13 months.
;
Observational Model: Cohort, Time Perspective: Prospective
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