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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia

Conditions
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Menorrhagia

Intervention / Treatment
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* Device: Extended treatment regimen using Her Option Cryotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Treatment Regimen<br>Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less. | Device: Extended treatment regimen using Her Option Cryotherapy<br>* Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.<br>* Other names: Her Option;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success (Reduction in Menstruation to Normal Levels) | 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. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menorrhagia, Excessive Uterine Bleeding, Cryoablation, Menstrual disorder, Endometrial ablation, Abnormal uterine bleeding, Dysfunctional uterine bleeding