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

Menorrhagia Clinical Trial

— CLARITY  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842736
• Other study ID #: CIP-0101
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2020

Study information

• Verified date: December 2020
• Source: Channel Medsystems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: May 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Device:
• Cerene(R) Cryotherapy Device

Locations

Country	Name	City	State
Canada	Allan Centre	Calgary	Alberta
Canada	LaSalle Hospital	Lasalle	Quebec
Mexico	Hospital Universitario de la Universidad Autónoma de Nuevo Leon	Monterrey	Nuevo Leon
United States	WomanCare PC	Arlington Heights	Illinois
United States	Asheville Women's Medical Center	Asheville	North Carolina
United States	Seven Hills Women's Health	Cincinnati	Ohio
United States	Women's Health Advantage	Fort Wayne	Indiana
United States	Amy Brenner MD and Associates, LLC	Mason	Ohio
United States	The Advance Gynecologic Surgery Institute	Naperville	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Basinski LLC	Newburgh	Indiana
United States	Premier Clinical Research	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Channel Medsystems

Countries where clinical trial is conducted

United States,  Canada,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjects' Report of Their Last Menstrual Period	Subjects were asked to describe their last menstrual period	36 months
Other	Menstrual Impact Questionnaire	Subjects' Report of Activity Limitations	36 months
Other	Premenstrual Symptoms Impact Survey	Subjects' Report of Pre-Menstrual Symptoms (PMS)	36 months
Other	Subject Satisfaction	Subject's level of satisfaction with the results of her Cerene treatment	36 Months
Other	Subject Recommendation	Subjects' reported level of recommendation to a friend/family	36 months
Other	Procedure Time	Device insertion to device removal	Day of Treatment
Other	Return to Normal Daily Activities		Two-Weeks
Primary	Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events		12 months
Primary	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	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
Secondary	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
Secondary	Investigator Evaluation of the Uterine Cavity		12 Months
Secondary	Investigator Assessment of Cavity Findings	Questions to the investigator	12 Months
Secondary	Anesthesia and Pain Medications at Treatment		Day of Treatment
Secondary	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