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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kelly Roy, M.D., P.C. | Phoenix | Arizona | 85013 | United States | ||
| Institute for Women's Health & Body |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Treatment Regimen | Extended treatment regimens using the Her Option Endometrial Cryotherapy System. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Inclusion Exclusion Evaluation |
|
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|
| Wellington |
| Florida |
| 33414 |
| United States |
| Lahey Clinic | Burlington | Massachusetts | 01805 | United States |
| Valley OB/GYN | Saginaw | Michigan | 48602 | United States |
| Center for Endometrial Ablation | Charlotte | North Carolina | 28262 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Jose Manjon, M.D. (Private practice) | Camp Hill | Pennsylvania | 17011 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment and Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Treatment Regimen | Extended treatment regimens using the Her Option Endometrial Cryotherapy System. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-Treat Analysis | Posted | Count of Participants | Participants | 1 Year |
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Adverse events were both passively and actively collected and assessed throughout the study, up to 3-years post-treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended Treatment Regimen | Extended treatment regimens using the Her Option Endometrial Cryotherapy System. | 19 | 82 | 16 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adnexial mass/cyst | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Bicep Tendon Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cancer - Breast | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dysmenorrhea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Failed Steriliztion Device Placement | Surgical and medical procedures | Systematic Assessment |
| ||
| Hematometria | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Labial Hypertrophy Surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Lumbar Fusion Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Menorrhagia/Lack of Efficacy | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Polycystic Ovarian Syndrome | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Shoulder Slap Lesion Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Urinary Incontinence Surgery | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Uterine Perforation During Sterilization Procedure | Surgical and medical procedures | Systematic Assessment |
| ||
| Umbilical Hernia Surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/Discomfort - Pelvic | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
| ||
| Vaginal Infection | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Endometritis | Reproductive system and breast disorders | Systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Cooper Surgical | 203-601-5200 | Robert.Auerbach@coopersurgical.com |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D008599 | Menstruation Disturbances |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Withdrawal by Subject |
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| Subject non-compliance |
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| Unable to attend visits |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Hispanic or Latino |
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