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

This study has been completed.
Sponsor:
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00094536
First received: October 20, 2004
Last updated: July 20, 2006
Last verified: July 2006
History of Changes
  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 perfomed 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
 Procedure: HerOption Endometrial Cryoablation Therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
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:

U.S. FDA Resources

Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • Evaluate the efficacy of the study treatment in reducing menstrual bleeding levels.

Secondary Outcome Measures:
  • Relieving pain/discomfort attributed to abnormal uterine bleeding (AUB) and improving quality of life.
  • Monitor the occurrence of side effects and/or complications associated with the study treatment.

Estimated Enrollment: 76
Study Start Date: April 2004
Estimated Study Completion Date: March 2008
Detailed Description:

American Medical Systems, Inc. (AMS) believes 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 and older
Genders 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 tranverse 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
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
American Medical Systems
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00094536     History of Changes
Other Study ID Numbers: AMS043
Study First Received: October 20, 2004
Last Updated: July 20, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by American Medical Systems:
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 May 22, 2013