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

NCT00094536 | Completed Phase 4 Results

• 1 other identifier: AMS043
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 7

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.

Conditions

Menorrhagia

Keywords

Menorrhagia; Excessive Uterine Bleeding; Cryoablation; Menstrual disorder; Endometrial ablation; Abnormal uterine bleeding; Dysfunctional uterine bleeding

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Extended Treatment Regimen

EXPERIMENTAL

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

Interventions

Extended treatment regimen using Her Option Cryotherapy DEVICE

Extended treatment regimens using the Her Option Endometrial Cryotherapy System to more effectively ablate the endometrial lining, reducing menstrual levels to normal or less.

Also known as: Her Option

Extended Treatment Regimen

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CooperSurgical Inc.: lead

Study Sites (7)

Kelly Roy, M.D., P.C.

Phoenix, Arizona, 85013, United States

Location

Institute for Women's Health & Body

Wellington, Florida, 33414, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Valley OB/GYN

Saginaw, Michigan, 48602, United States

Location

Center for Endometrial Ablation

Charlotte, North Carolina, 28262, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Jose Manjon, M.D. (Private practice)

Camp Hill, Pennsylvania, 17011, United States

Location

MeSH Terms

Conditions

Menorrhagia; Menstruation Disturbances; Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The primary endpoint was assessed using a validated diary completed by the subject prior to each visit, which has inherent weaknesses as an objective measure of blood loss. Use of historical control limits comparison of outcomes across studies.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Cooper Surgical

Robert.Auerbach@coopersurgical.com

203-601-5200

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2004
• First Posted: October 21, 2004
• Study Start: April 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: June 1, 2009
• Last Updated: March 3, 2017
• Results First Posted: March 3, 2017

Record last verified: 2017-03

Locations

US (7)