This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CooperSurgical Inc.
ClinicalTrials.gov Identifier:
NCT00094536
First received: October 20, 2004
Last updated: March 1, 2017
Last verified: March 2017
  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 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.


Condition Intervention Phase
Menorrhagia Device: Extended treatment regimen using Her Option Cryotherapy Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Official Title: A Study to Evaluate the Effectiveness of Extended Treatment Regimens With the Her Option® Cryoablation Therapy System for Treatment of Menorrhagia

Resource links provided by NLM:


Further study details as provided by CooperSurgical Inc.:

Primary Outcome Measures:
  • 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.


Enrollment: 82
Study Start Date: April 2004
Study Completion Date: June 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Her Option

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.
  Eligibility

Ages Eligible for Study:   30 Years to 100 Years   (Adult, Senior)
Sexes 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Center for Endometrial Ablation
Charlotte, North Carolina, United States, 28262
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Jose Manjon, M.D. (Private practice)
Camp Hill, Pennsylvania, United States, 17011
Sponsors and Collaborators
CooperSurgical Inc.
  More Information

Additional Information:
Responsible Party: CooperSurgical Inc.
ClinicalTrials.gov Identifier: NCT00094536     History of Changes
Other Study ID Numbers: AMS043
Study First Received: October 20, 2004
Results First Received: March 9, 2010
Last Updated: March 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by CooperSurgical Inc.:
Menorrhagia
Excessive Uterine Bleeding
Cryoablation
Menstrual disorder
Endometrial ablation
Abnormal uterine bleeding
Dysfunctional uterine bleeding

Additional relevant MeSH terms:
Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on August 16, 2017