N/A
N=242
A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
Menorrhagia
Bottom Line
View on ClinicalTrials.gov: NCT02842736 ↗Enrolled (actual)
242
Serious AEs
2.5%
Results posted
Jun 2019
Primary outcome: Primary: Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events — 7; 0 Reports of events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cerene(R) Cryotherapy Device (Device)
- Age
- Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Channel Medsystems
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events |
7; 0 | — |
| PRIMARY Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75 |
186 | — |
| SECONDARY Dysmennorhea |
74; 70; 40; 33; 10; 3 | — |
| SECONDARY Amenorrhea |
25 | — |
| SECONDARY Investigator Evaluation of the Uterine Cavity |
220; 3; 204; 19 | — |
| SECONDARY Investigator Assessment of Cavity Findings |
178; 26; 195; 9 | — |
| SECONDARY Anesthesia and Pain Medications at Treatment |
20; 48; 167; 7; 0 | — |
| SECONDARY Subject Rating of Pain During Treatment and Day One Post-Treatment |
1; 2; 1; 2; 1; 2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02842736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.