Status:
COMPLETED
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System
Lead Sponsor:
CooperSurgical Inc.
Conditions:
Menorrhagia
Eligibility:
FEMALE
30-100 years
Phase:
PHASE4
Brief Summary
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) d...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00094536
Start Date
April 1 2004
End Date
June 1 2009
Last Update
March 3 2017
Active Locations (7)
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1
Kelly Roy, M.D., P.C.
Phoenix, Arizona, United States, 85013
2
Institute for Women's Health & Body
Wellington, Florida, United States, 33414
3
Lahey Clinic
Burlington, Massachusetts, United States, 01805
4
Valley OB/GYN
Saginaw, Michigan, United States, 48602