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| Sponsor: | Halt Medical, Inc |
|---|---|
| Information provided by: | Halt Medical, Inc |
| ClinicalTrials.gov Identifier: | NCT00874029 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Uterine Fibroids Uterine Myomas |
Device: Halt Fibroid System |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation |
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
If the woman is currently taking hormonal contraceptives, has taken hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through 12 months of follow up.**
**Note: Hormonal contraceptive use must be terminated 30 days prior to treatment but should be resumed post-operatively within 60 days post treatment as instructed by the Investigator.
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Women's Health Research | |
| Phoenix, Arizona, United States, 85015 | |
| United States, California | |
| USC Medical Center | |
| Los Angeles, California, United States, 90033 | |
| Pasadena Premier Women's Health | |
| Pasadena, California, United States, 91145 | |
| Reproductive Science Center | |
| San Ramon, California, United States, 94583 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48034 | |
| United States, Missouri | |
| St. Luke's Hospital | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, Nevada | |
| Athena Gynecology Medical Group | |
| Reno, Nevada, United States, 89509 | |
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10461 | |
| United States, Pennsylvania | |
| Magee-Women's Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Guatemala | |
| Hospital Universitario Esperanza | |
| Guatemala City, Guatemala, 01010 | |
| Mexico | |
| Hospital Universitario Dr. Jose Eleuterio Gonzalez de la Universidad Autonoma de Nuevo Leon. Facultad de Medicina | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
| Principal Investigator: | Donald Galen, MD | Reproductive Science Center |
| Principal Investigator: | Micah Harris, MD | Women's Health Research |
| Principal Investigator: | Erika Banks, MD | Montefiore Medical Center |
| Principal Investigator: | Karen R Abbott, MD | Athena Gynecology Medical Group |
| Principal Investigator: | Jay Berman, MD | Wayne State University |
| Principal Investigator: | Jose G Garza Leal, MD | Hospital Universitario Dr. Jose Eleuterio Gonzalez |
| Principal Investigator: | David Levine, MD | St. Johns' Mercy Medical Center |
| Principal Investigator: | Rodolfo Robles Pemueller, MD | Universidad Francisco Marroquin |
| Principal Investigator: | Ian Tilley, MD | University of Southern California |
| Principal Investigator: | Richard S Guido, MD | Magee-Women's Hospital |
| Principal Investigator: | James Macer, MD | Pasadena Premier Women's Health |
More Information
| Responsible Party: | Julie Sanders - Clinical Trials Mgr, Halt Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00874029 History of Changes |
| Other Study ID Numbers: | CP-00-0004 |
| Study First Received: | April 1, 2009 |
| Last Updated: | May 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Uterine Fibroids Myomas |
|
Leiomyoma Myofibroma Myoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |