NCT00874029

Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids

Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Acessa Health, Inc. · Industry
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this single-arm study, subjects who have symptomatic uterine fibroids will have laparoscopic surgery in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.

Conditions

• Uterine Fibroids
• Uterine Myomas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-01-01
• Completion: 2014-03-01
• First posted: 2009-04-02
• Last updated: 2014-07-03
• Results posted: 2014-07-03

Locations

11 sites across 3 countries: United States, Guatemala, Mexico