Fibroid Ablation Study
NCT01226290 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2015-04-02
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.
Conditions
- Leiomyoma
- Uterine Fibroids
- Menorrhagia
Interventions
- DEVICE
-
VizAblate System
VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.
Sponsors & Collaborators
-
Gynesonics
lead INDUSTRY
Principal Investigators
-
David Toub, MD · Gynesonics
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 28 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2014-03-31
- Completion
- 2014-03-31
Countries
- Mexico
- Netherlands
- United Kingdom
Study Locations
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