A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.

Conditions
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Menorrhagia

Intervention / Treatment
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* Device: Cerene(R) Cryotherapy Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Refractory heavy menstrual bleeding with no definable organic cause Female subject age 25 to 50 years, inclusive Sounded length of uterine cavity no greater than 10 cm and endometrial cavity no greater than 6.5 cm Sufficient myometrial thickness Documented excessive menstrual blood loss within 3 months of informed consent Premenopausal confirmed by follicle stimulating hormone (FSH) measurement Agrees to use a reliable form of contraception following ablation treatment Provides written informed consent using a form that has been approved by the reviewing ethics committee Agrees to follow-up exams and data collection requirements Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram Has predictable, cyclic menstrual cycles Exclusion Criteria: Pregnant or has a desire to conceive Endometrial hyperplasia as confirmed by histology Active endometritis Active pelvic inflammatory disease Active sexually transmitted disease (STD) Presence of bacteremia, sepsis, or other active systemic infection Active infection of the genitals, vagina, cervix, or uterus Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years Known clotting defects or bleeding disorders Abnormal cytology on Human papillomavirus (HPV) testing not treated according to local standards. Prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section). Previous low transverse cesarean section where the myometrial wall thickness is insufficient Previous endometrial ablation procedure Clinically significant adenomyosis indicated by subject complaints, imaging, or clinician's judgment Presence of an implantable contraceptive device Currently on medications that could thin the myometrial muscle Currently on anticoagulants Abnormal or obstructed cavity Currently using an intrauterine device (IUD) and unwilling to remove the IUD Post-partum ≤ 6-months Considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could represent an increased risk for the subject or impact the subject's ability to comply with protocol requirements

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial Cryoablation<br> | Device: Cerene(R) Cryotherapy Device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events |  | 12 months | 
| Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75 | Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75. Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysmennorhea | Subjects were queried regarding if they suffer from dysmenorrhea (painful cramping associated with menstruation). The subject was asked to rate their level of dysmenorrhea on a scale from 0 to 5, with 0 indicating no symptoms and 5 indicating very severe symptoms. A score of 0 was considered better than a score of 5. | 12 Months | 
| Amenorrhea | Pictorial blood loss assessment (PBLAC) score = 0 Scale information for PBLAC (Pictorial Blood Loss Assessment Chart): The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding. | 12 Months | 
| Investigator Evaluation of the Uterine Cavity |  | 12 Months | 
| Investigator Assessment of Cavity Findings | Questions to the investigator | 12 Months | 
| Anesthesia and Pain Medications at Treatment |  | Day of Treatment | 
| Subject Rating of Pain During Treatment and Day One Post-Treatment | Pain rating using numeric rating scale, minimum 0, maximum 10, with 0 designated as no pain and 10 designated as the worst pain. | Day of Treatment and Day One Post-Treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heavy menstrual bleeding, endometrial ablation