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Completed

NCT Number: NCT02842736

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

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.

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Allan Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cerene(R) Cryotherapy Device

Device

Primary outcomes

  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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Investigator Evaluation of the Uterine Cavity

    Time frame: 12 Months

  4. Investigator Assessment of Cavity Findings

    Time frame: 12 Months

    Questions to the investigator

  5. Anesthesia and Pain Medications at Treatment

    Time frame: Day of Treatment

  6. 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.

Other outcomes

  1. Subjects' Report of Their Last Menstrual Period

    Time frame: 36 months

    Subjects were asked to describe their last menstrual period

  2. Menstrual Impact Questionnaire

    Time frame: 36 months

    Subjects' Report of Activity Limitations

  3. Premenstrual Symptoms Impact Survey

    Time frame: 36 months

    Subjects' Report of Pre-Menstrual Symptoms (PMS)

  4. Subject Satisfaction

    Time frame: 36 Months

    Subject's level of satisfaction with the results of her Cerene treatment

  5. Subject Recommendation

    Time frame: 36 months

    Subjects' reported level of recommendation to a friend/family

  6. Procedure Time

    Time frame: Day of Treatment

    Device insertion to device removal

  7. Return to Normal Daily Activities

    Time frame: Two-Weeks

Sponsors and collaborators

Lead sponsor

Channel Medsystems

Industry

Registry information

Acronym: CLARITY

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jul 25, 2016
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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