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Brief Title: Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
Official Title: Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation
Study ID: NCT00874029
Brief 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.
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Women's Health Research, Phoenix, Arizona, United States
USC Medical Center, Los Angeles, California, United States
Pasadena Premier Women's Health, Pasadena, California, United States
Reproductive Science Center, San Ramon, California, United States
Wayne State University, Detroit, Michigan, United States
St. Luke's Hospital, Chesterfield, Missouri, United States
Athena Gynecology Medical Group, Reno, Nevada, United States
Montefiore Medical Center, Bronx, New York, United States
Magee-Women's Hospital, Pittsburgh, Pennsylvania, United States
Hospital Universitario Esperanza, Guatemala City, , Guatemala
Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina, Monterrey, Nuevo Leon, Mexico
Name: Mary Hinckley, MD
Affiliation: Reproductive Science Center
Role: PRINCIPAL_INVESTIGATOR
Name: Micah Harris, MD
Affiliation: Women's Health Research
Role: PRINCIPAL_INVESTIGATOR
Name: Erika Banks, MD
Affiliation: Montefiore Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Karen R Abbott, MD
Affiliation: Athena Gynecology Medical Group
Role: PRINCIPAL_INVESTIGATOR
Name: Jay Berman, MD
Affiliation: Wayne State University
Role: PRINCIPAL_INVESTIGATOR
Name: Jose G Garza Leal, MD
Affiliation: Hospital Universitario Dr. Jose Eleuterio Gonzalez
Role: PRINCIPAL_INVESTIGATOR
Name: David Levine, MD
Affiliation: St. Johns' Mercy Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: Rodolfo Robles Pemueller, MD
Affiliation: Universidad Francisco Marroquín
Role: PRINCIPAL_INVESTIGATOR
Name: Jennifer Israel, MD
Affiliation: University of Southern California
Role: PRINCIPAL_INVESTIGATOR
Name: Richard S Guido, MD
Affiliation: Magee-Women's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: James Macer, MD
Affiliation: Pasadena Premier Women's Health
Role: PRINCIPAL_INVESTIGATOR