Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842736
Recruitment Status : Completed
First Posted : July 25, 2016
Results First Posted : June 6, 2019
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Channel Medsystems

Tracking Information
First Submitted Date  ICMJE July 21, 2016
First Posted Date  ICMJE July 25, 2016
Results First Submitted Date  ICMJE April 25, 2019
Results First Posted Date  ICMJE June 6, 2019
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
  • Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events [ Time Frame: 12 months ]
  • Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75 [ Time Frame: 12 months ]
    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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2020)
  • Dysmennorhea [ Time Frame: 12 Months ]
    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.
  • Amenorrhea [ Time Frame: 12 Months ]
    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.
  • Investigator Evaluation of the Uterine Cavity [ Time Frame: 12 Months ]
  • Investigator Assessment of Cavity Findings [ Time Frame: 12 Months ]
    Questions to the investigator
  • Anesthesia and Pain Medications at Treatment [ Time Frame: Day of Treatment ]
  • Subject Rating of Pain During Treatment and Day One Post-Treatment [ Time Frame: Day of 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 10, 2020)
  • Subjects' Report of Their Last Menstrual Period [ Time Frame: 36 months ]
    Subjects were asked to describe their last menstrual period
  • Menstrual Impact Questionnaire [ Time Frame: 36 months ]
    Subjects' Report of Activity Limitations
  • Premenstrual Symptoms Impact Survey [ Time Frame: 36 months ]
    Subjects' Report of Pre-Menstrual Symptoms (PMS)
  • Subject Satisfaction [ Time Frame: 36 Months ]
    Subject's level of satisfaction with the results of her Cerene treatment
  • Subject Recommendation [ Time Frame: 36 months ]
    Subjects' reported level of recommendation to a friend/family
  • Procedure Time [ Time Frame: Day of Treatment ]
    Device insertion to device removal
  • Return to Normal Daily Activities [ Time Frame: Two-Weeks ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Menorrhagia
Intervention  ICMJE Device: Cerene(R) Cryotherapy Device
Study Arms  ICMJE Experimental: Endometrial Cryoablation
Intervention: Device: Cerene(R) Cryotherapy Device
Publications * Curlin HL, Cintron LC, Anderson TL. A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding. J Minim Invasive Gynecol. 2021 Apr;28(4):899-908. doi: 10.1016/j.jmig.2020.08.013. Epub 2020 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2016)
242
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2020
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02842736
Other Study ID Numbers  ICMJE CIP-0101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Channel Medsystems
Study Sponsor  ICMJE Channel Medsystems
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Channel Medsystems
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP