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Fibroid Ablation Study - Large Fibroids

NCT01539187 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-03-17

No results posted yet for this study

Summary

The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (\> 5 cm) 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
2012-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Mexico
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539187 on ClinicalTrials.gov