Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System - Full Text View

Sponsored by:	American Medical Systems
Information provided by:	American Medical Systems
ClinicalTrials.gov Identifier:	NCT00094536

Purpose

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 perfomed 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.

Condition	Intervention	Phase
Menorrhagia	Procedure: HerOption Endometrial Cryoablation Therapy	Phase IV

MedlinePlus related topics: Menstruation Vaginal Bleeding

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title:	A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia

Further study details as provided by American Medical Systems:

Primary Outcome Measures:

Evaluate the efficacy of the study treatment in reducing menstrual bleeding levels.

Secondary Outcome Measures:

Relieving pain/discomfort attributed to abnormal uterine bleeding (AUB) and improving quality of life.
Monitor the occurrence of side effects and/or complications associated with the study treatment.

Estimated Enrollment:	76
Study Start Date:	April 2004
Estimated Study Completion Date:	March 2008

Detailed Description:

American Medical Systems, Inc. (AMS) believes 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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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 tranverse 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094536

Locations

United States, Arizona
Kelly Roy, M.D., P.C.
Phoenix, Arizona, United States, 85013
United States, Florida
Institute for Women’s Health & Body
Wellington, Florida, United States, 33414
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
Valley OB/GYN
Saginaw, Michigan, United States, 48602
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Center for Endometrial Ablation
Charlotte, North Carolina, United States, 28262
United States, Pennsylvania
Jose Manjon, M.D. (Private practice)
Camp Hill, Pennsylvania, United States, 17011

Sponsors and Collaborators

American Medical Systems

More Information

Study ID Numbers:	AMS043
Study First Received:	October 20, 2004
Last Updated:	July 20, 2006
ClinicalTrials.gov Identifier:	NCT00094536
Health Authority:	United States: Food and Drug Administration

Keywords provided by American Medical Systems:

Menorrhagia
Excessive Uterine Bleeding
Cryoablation
Menstrual disorder

Endometrial ablation
Abnormal uterine bleeding
Dysfunctional uterine bleeding

Study placed in the following topic categories:

Genital Diseases, Female
Menstruation Disturbances
Metrorrhagia
Uterine Hemorrhage

Uterine Diseases
Menorrhagia
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009