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

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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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

30 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kelly Roy, M.D., P.C., Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended treatment regimen using Her Option Cryotherapy

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.

Other names: Her Option

Primary outcomes

Success (Reduction in Menstruation to Normal Levels)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

CooperSurgical Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2009
First posted: Oct 21, 2004
Registry last updated: Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed