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

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

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.

Study Overview

• Status: Completed
• Conditions: Menorrhagia
• Intervention / Treatment: Device: Extended treatment regimen using Her Option Cryotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Her Option

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CooperSurgical Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: October 20, 2004
• First Submitted That Met QC Criteria: October 20, 2004
• First Posted (Estimate): October 21, 2004

Study Record Updates

• Last Update Posted (Actual): March 3, 2017
• Last Update Submitted That Met QC Criteria: March 1, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Cryoablation; Menorrhagia; Excessive Uterine Bleeding; Abnormal uterine bleeding; Dysfunctional uterine bleeding; Endometrial ablation; Menstrual disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Uterine Diseases; Hemorrhage; Menstruation Disturbances; Uterine Hemorrhage; Menorrhagia
• Other Study ID Numbers: AMS043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED