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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 : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Channel Medsystems

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.

Condition or disease Intervention/treatment Phase
Menorrhagia Device: Cerene(R) Cryotherapy Device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endometrial Cryoablation Device: Cerene(R) Cryotherapy Device



Primary Outcome Measures :
  1. Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events [ Time Frame: 12 months ]
  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842736


Locations
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United States, Illinois
WomanCare PC
Arlington Heights, Illinois, United States, 60004
The Advance Gynecologic Surgery Institute
Naperville, Illinois, United States, 60540
United States, Indiana
Women's Health Advantage
Fort Wayne, Indiana, United States, 46825
Basinski LLC
Newburgh, Indiana, United States, 47630
United States, North Carolina
Asheville Women's Medical Center
Asheville, North Carolina, United States, 28801
United States, Ohio
Seven Hills Women's Health
Cincinnati, Ohio, United States, 45231
Amy Brenner MD and Associates, LLC
Mason, Ohio, United States, 45040
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99202
Canada, Alberta
Allan Centre
Calgary, Alberta, Canada, T2J 7G9
Canada, Quebec
LaSalle Hospital
Lasalle, Quebec, Canada, H8P 1C1
Mexico
Hospital Universitario de la Universidad Autónoma de Nuevo Leon
Monterrey, Nuevo Leon, Mexico, 66460
Sponsors and Collaborators
Channel Medsystems
  Study Documents (Full-Text)

Documents provided by Channel Medsystems:
Study Protocol  [PDF] October 12, 2018
Statistical Analysis Plan  [PDF] June 29, 2016

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Responsible Party: Channel Medsystems
ClinicalTrials.gov Identifier: NCT02842736    
Other Study ID Numbers: CIP-0101
First Posted: July 25, 2016    Key Record Dates
Results First Posted: June 6, 2019
Last Update Posted: May 22, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Channel Medsystems:
heavy menstrual bleeding
endometrial ablation
Additional relevant MeSH terms:
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Menorrhagia
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Pathologic Processes
Menstruation Disturbances