Menorrhagia
Conditions
Keywords
Menorrhagia, Excessive Uterine Bleeding, Cryoablation, Menstrual disorder, Endometrial ablation, Abnormal uterine bleeding, Dysfunctional uterine bleeding
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.
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.
Interventions
DEVICEExtended 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.
Sponsors
CooperSurgical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Extended Treatment Regimen Extended treatment regimens using the Her Option Endometrial Cryotherapy System. | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Inclusion Exclusion Evaluation | Did not qualify for study treatment | 24 |
| Treatment and Follow-up | Adverse Event | 4 |
| Treatment and Follow-up | Lack of Efficacy | 9 |
| Treatment and Follow-up | Lost to Follow-up | 7 |
| Treatment and Follow-up | Subject non-compliance | 9 |
| Treatment and Follow-up | Unable to attend visits | 1 |
| Treatment and Follow-up | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Extended Treatment Regimen |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 0 participants |
| Race/Ethnicity, Customized Black or African American | 16 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 9 participants |
| Race/Ethnicity, Customized More than one race | 2 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 participants |
| Race/Ethnicity, Customized White | 79 participants |
| Region of Enrollment United States | 106 participants |
| Sex: Female, Male Female | 106 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 82 |
| serious Total, serious adverse events | 19 / 82 |
Outcome results
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.
Time frame: 1 Year
Population: Intention-to-Treat Analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Treatment Regimen | Success (Reduction in Menstruation to Normal Levels) | 59 Participants |
p-value: 0.2711-sided z-test