Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CooperSurgical Inc.
American Medical Systems, Inc. (AMS) hypothesized 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.
Age
30–100
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Pre-menopausal adult women 30 years of age or older who have completed childbearing
Heavy or prolonged menstrual bleeding
Willing and able to complete all follow-up exams as required by protocol
You may not be if
Known or suspected endometrial cancer or pre-malignant change of the endometrium
Untreated cervical dysplasia
Hereditary malformations of the uterine cavity that would prevent insertion and/or placement of the cryoprobe
Uterine myomas \> or = to 3 cm in diameter
Past history of invasive treatment for abnormal uterine bleeding or uterine myomas
History of classical (not low transverse incision) cesarean section
Active genital or urinary tract infection or acute pelvic inflammatory disease (PID)
Intrauterine device (IUD) in place
Other medical conditions could be exclusionary upon evaluation for study treatment
Clareo Health | Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
