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

Menorrhagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00094536
• Other study ID #: AMS043
• Status: Completed
• Phase: Phase 4
• First received: October 20, 2004
• Last updated: March 1, 2017
• Start date: April 2004
• Est. completion date: June 2009

Study information

• Verified date: March 2017
• Source: CooperSurgical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 100 Years

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

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Device:
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
CooperSurgical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Cooper Surgical acquired the Her Option product as of 2/16/2010