Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

Summary

The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.

Conditions

• Uterine Fibroids
• Uterine Myomas

Interventions

DEVICE

Halt Procedure

The Halt 2000 Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic and intraoperative, coagulation and ablation of soft tissue.

Sponsors & Collaborators

• Acessa Health, Inc.

  lead INDUSTRY

Principal Investigators

• Mary Hinckley, MD · Reproductive Science Center

• Micah Harris, MD · Women's Health Research

• Erika Banks, MD · Montefiore Medical Center

• Karen R Abbott, MD · Athena Gynecology Medical Group

• Jay Berman, MD · Wayne State University

• Jose G Garza Leal, MD · Hospital Universitario Dr. Jose Eleuterio Gonzalez

• David Levine, MD · St. Johns' Mercy Medical Center

• Rodolfo Robles Pemueller, MD · Universidad Francisco Marroquín

• Jennifer Israel, MD · University of Southern California

• Richard S Guido, MD · Magee-Women's Hospital

• James Macer, MD · Pasadena Premier Women's Health

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2012-01-31

Completion

2014-03-31

Countries

• United States
• Guatemala
• Mexico

Study Locations