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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.


Detailed Summary: 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.
Sponsor: CooperSurgical Inc.

Current Primary Outcome: 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.


Original Primary Outcome:

  • 1) Evaluate the efficacy of the study treatment in reducing menstrual bleeding levels.
  • 2) Relieving pain/discomfort attributed to abnormal uterine bleeding (AUB) and improving quality of life.
  • 3) Monitor the occurrence of side effects and/or complications associated with the study treatment.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: CooperSurgical Inc.

Dates:
Date Received: October 20, 2004
Date Started: April 2004
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017