MedTrace Logo

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

NCT00094536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2017-03-03

Study results available
· View outcomes & findings →

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.

Conditions

  • Menorrhagia

Interventions

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.

Sponsors & Collaborators

  • CooperSurgical Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-10-31
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00094536 on ClinicalTrials.gov