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VizAblate System with subject serving as her own control

The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids

VizAblate System

David Toub, MD

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 Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation

The cavity will be as classified per the European Society for Hysteroscopy (ESH)

Frequency and type of adverse events occurring on the day of the procedure

Frequency and type of adverse events occurring post treatment through 12 months

Gynesonics

VizAblate System: subject acts as her own control

VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.

The primary objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.

Fibroid Ablation Study

Symptom Effectiveness Study of VizAblate™ Intrauterine Ultrasound-Guided RF Ablation (IUUSgRFA) in the Ablation of Uterine Fibroids

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Observational Prospective Study on Patients With Symptomatic Uterine Fibroids Treated With VizAblate® Intrauterine-ultrasound Guided RF Ablation	NCT01998854	Menorrhagia Leiomyoma Uterine Fibroid... Uterine Fibroma Uterine Neoplas...	VizAblate Syste...	28 Years -	Gynesonics
Fibroid Ablation Study	NCT01226290	Leiomyoma Uterine Fibroid... Menorrhagia	VizAblate Syste...	28 Years -	Gynesonics
Fibroid Ablation Study	NCT01226290	Leiomyoma Uterine Fibroid... Menorrhagia	VizAblate Syste...	28 Years -	Gynesonics

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