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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-06-30

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.

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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.

Conditions

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Menorrhagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Extended Treatment Regimen

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

Group Type EXPERIMENTAL

Extended treatment regimen using Her Option Cryotherapy

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Her Option

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No