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

• Sponsor: CooperSurgical Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00094536
• Collaborator: (none)
• Enrollment: 82
• Locations: 7
• Arm: 1
• Duration (Months): 62
• Patients Per Site: 11.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Menorrhagia	Device: Extended treatment regimen using Her Option Cryotherapy	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• 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
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Her Option

Outcome Measures

Primary Outcome Measures

1. Success (Reduction in Menstruation to Normal Levels) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Kelly Roy, M.D., P.C.	Phoenix	Arizona	United States	85013
2	Institute for Women's Health & Body	Wellington	Florida	United States	33414
3	Lahey Clinic	Burlington	Massachusetts	United States	01805
4	Valley OB/GYN	Saginaw	Michigan	United States	48602
5	Center for Endometrial Ablation	Charlotte	North Carolina	United States	28262
6	Duke University Medical Center	Durham	North Carolina	United States	27710
7	Jose Manjon, M.D. (Private practice)	Camp Hill	Pennsylvania	United States	17011

Sponsors and Collaborators

• CooperSurgical Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CooperSurgical Inc.
• ClinicalTrials.gov Identifier: NCT00094536
• Other Study ID Numbers: AMS043
• First Posted: Oct 21, 2004
• Last Update Posted: Mar 3, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• 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

Study Results

Participant Flow

Recruitment Details	Enrollment commenced 8/13/04, and was completed 1/20/06, with final 3-year follow-up occurring on 3/17/09. Assessments occurred at gynecologic offices. The majority of procedures occurred in the office setting, and the remainder in the ASC setting.
Pre-assignment Detail	Subjects were consented and assessed for inclusion/exclusion; qualified subjects underwent treatment and are considered the intent-to-treat group. Sample size was targeted for 76 subjects, however FDA granted the request for additional subjects to undergo treatment if consented at the time of completion of enrollment.

Arm/Group Title	Extended Treatment Regimen
Arm/Group Description	Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
Period Title: Inclusion Exclusion Evaluation
STARTED	106
COMPLETED	82
NOT COMPLETED	24
Period Title: Inclusion Exclusion Evaluation
STARTED	82
12 Month Follow-up	69
24 Month Follow-up	53
36 Month Follow-up	51
COMPLETED	51
NOT COMPLETED	31

Baseline Characteristics

Arm/Group Title	Extended Treatment Regimen
Arm/Group Description	Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
Overall Participants	106
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	106 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	106 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	9 8.5%
Not Hispanic or Latino	97 91.5%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	16 15.1%
White	79 74.5%
More than one race	2 1.9%
Unknown or Not Reported	0 0%
Hispanic or Latino	9 8.5%
Region of Enrollment (participants) [Number]
United States	106 100%

Outcome Measures

1. Primary Outcome

Title	Success (Reduction in Menstruation to Normal Levels)
Description	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.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

Intention-to-Treat Analysis

Arm/Group Title	Extended Treatment Regimen
Arm/Group Description	Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
Measure Participants	82
Count of Participants [Participants]	59 55.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Extended Treatment Regimen
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.271
	Comments
	Method	1-sided z-test
	Comments	1-sided z-test with continuity correction (pooled)

Adverse Events

Time Frame	Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
Arm/Group Title	Extended Treatment Regimen
Arm/Group Description	Extended treatment regimens using the Her Option Endometrial Cryotherapy System.
All Cause Mortality
	Extended Treatment Regimen
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Extended Treatment Regimen
	Affected / at Risk (%)	# Events
Total	19/82 (23.2%)
Musculoskeletal and connective tissue disorders
Bicep Tendon Surgery	1/82 (1.2%)	1
Lumbar Fusion Surgery	1/82 (1.2%)	1
Shoulder Slap Lesion Surgery	1/82 (1.2%)	1
Umbilical Hernia Surgery	1/82 (1.2%)	1
Renal and urinary disorders
Urinary Incontinence Surgery	1/82 (1.2%)	1
Urinary Tract Infection	1/82 (1.2%)	1
Reproductive system and breast disorders
Adnexial mass/cyst	1/82 (1.2%)	1
Cancer - Breast	1/82 (1.2%)	1
Dysmenorrhea	1/82 (1.2%)	1
Endometriosis	1/82 (1.2%)	1
Hematometria	1/82 (1.2%)	1
Menorrhagia/Lack of Efficacy	6/82 (7.3%)	6
Polycystic Ovarian Syndrome	1/82 (1.2%)	2
Surgical and medical procedures
Failed Steriliztion Device Placement	1/82 (1.2%)	1
Labial Hypertrophy Surgery	1/82 (1.2%)	1
Uterine Perforation During Sterilization Procedure	1/82 (1.2%)	1
Other (Not Including Serious) Adverse Events
	Extended Treatment Regimen
	Affected / at Risk (%)	# Events
Total	16/82 (19.5%)
Renal and urinary disorders
Urinary Tract Infection	4/82 (4.9%)	4
Reproductive system and breast disorders
Pain/Discomfort - Pelvic	5/82 (6.1%)	5
Vaginal Infection	4/82 (4.9%)	4
Endometritis	3/82 (3.7%)	3

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.