Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System

Phase 4

Completed

Interventions: Device: Extended treatment regimen using Her Option Cryotherapy

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) due to benign causes. This is a non-incisional procedure, which can be performed 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.

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 uterine bleeding was not optimal and that extended freeze regimens will result in improved outcomes for patients.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Extended Treatment Regimen	Extended treatment regimen using Her Option Cryotherapy	Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.

Primary Outcome Measures

Name	Time	Method
Success (Reduction in Menstruation to Normal Levels)	1 Year	Success is defined as a pictorial bleeding assessment chart (PBAC) score of ≤ 75 at 1-year post-treatment; a score which corresponds to normal menstruation levels.

Secondary Outcome Measures

Name	Time	Method

Locations (7): Center for Endometrial Ablation
🇺🇸
Charlotte, North Carolina, United States
Institute for Women's Health & Body
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Wellington, Florida, United States
Jose Manjon, M.D. (Private practice)
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Camp Hill, Pennsylvania, United States
Valley OB/GYN
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Saginaw, Michigan, United States
Duke University Medical Center
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Durham, North Carolina, United States
Kelly Roy, M.D., P.C.
🇺🇸
Phoenix, Arizona, United States
Lahey Clinic
🇺🇸
Burlington, Massachusetts, United States