Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Leiomyoma

Myofibroma

Menorrhagia

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Hemorrhage

Uterine Hemorrhage

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Menstruation Disturbances

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.

VizAblate System

David Toub, MD

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.

Gynesonics

VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.

VizAblate Intrauterine Ultrasound-Guided RF Ablation

David Toub, M.D.

The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.

Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study

Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study	NCT00768742	Leiomyoma Uterine Fibroid... Menorrhagia	VizAblate Intra...	25 Years -	Gynesonics
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study	NCT00768742	Leiomyoma Uterine Fibroid... Menorrhagia	VizAblate Intra...	25 Years -	Gynesonics

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