Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be perfomed in a physicians office with minimal sedation.
Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6 minutes with the Cryoprobe repositioned in the contralateral cornu.
Since completion of the early studies, many physicians have experimented with varying freeze patterns using longer freeze durations and/or additional freezes at the fundus and the lower uterine segment. The results, as reported in the literature, indicate that these extended freeze patterns produce significantly better results than the original regimen.
Procedure: HerOption Endometrial Cryoablation Therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|Official Title:||A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia|
- Evaluate the efficacy of the study treatment in reducing menstrual bleeding levels.
- Relieving pain/discomfort attributed to abnormal uterine bleeding (AUB) and improving quality of life.
- Monitor the occurrence of side effects and/or complications associated with the study treatment.
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||March 2008|
American Medical Systems, Inc. (AMS) believes that the original treatment pattern used to support a previous FDA approval for the Her Option® Cryoablation Therapy System for Treatment of abnormal uterine bleeding was not optimal and that extended freeze regimens will result in improved outcomes for patients.
|United States, Arizona|
|Kelly Roy, M.D., P.C.|
|Phoenix, Arizona, United States, 85013|
|United States, Florida|
|Institute for Women’s Health & Body|
|Wellington, Florida, United States, 33414|
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|United States, Michigan|
|Saginaw, Michigan, United States, 48602|
|United States, North Carolina|
|Center for Endometrial Ablation|
|Charlotte, North Carolina, United States, 28262|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Jose Manjon, M.D. (Private practice)|
|Camp Hill, Pennsylvania, United States, 17011|