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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endometrial Cryoablation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerene(R) Cryotherapy Device | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events | 12 months | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects' Report of Their Last Menstrual Period | Subjects were asked to describe their last menstrual period | 36 months |
| Menstrual Impact Questionnaire | Subjects' Report of Activity Limitations |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WomanCare PC | Arlington Heights | Illinois | 60004 | United States | ||
| The Advance Gynecologic Surgery Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35983177 | Derived | Curlin HL, Anderson TL. Endometrial Cryoablation for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the CLARITY Study. Int J Womens Health. 2022 Aug 10;14:1083-1092. doi: 10.2147/IJWH.S371044. eCollection 2022. | |
| 34839060 | Derived | Curlin H, Cholkeri-Singh A, Leal JGG, Anderson T. Hysteroscopic Access and Uterine Cavity Evaluation 12 Months after Endometrial Ablation with the Cerene Cryotherapy Device. J Minim Invasive Gynecol. 2022 Mar;29(3):440-447. doi: 10.1016/j.jmig.2021.11.016. Epub 2021 Nov 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Endometrial Cryoablation | Cerene(R) Cryotherapy Device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2018 | Apr 25, 2019 |
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| 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 |
| Investigator Evaluation of the Uterine Cavity | 12 Months |
| Investigator Assessment of Cavity Findings | Questions to the investigator | 12 Months |
| Anesthesia and Pain Medications at Treatment | Day of Treatment |
| 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 |
| 36 months |
| Premenstrual Symptoms Impact Survey | Subjects' Report of Pre-Menstrual Symptoms (PMS) | 36 months |
| Subject Satisfaction | Subject's level of satisfaction with the results of her Cerene treatment | 36 Months |
| Subject Recommendation | Subjects' reported level of recommendation to a friend/family | 36 months |
| Procedure Time | Device insertion to device removal | Day of Treatment |
| Return to Normal Daily Activities | Two-Weeks |
| Naperville |
| Illinois |
| 60540 |
| United States |
| Women's Health Advantage | Fort Wayne | Indiana | 46825 | United States |
| Basinski LLC | Newburgh | Indiana | 47630 | United States |
| Asheville Women's Medical Center | Asheville | North Carolina | 28801 | United States |
| Seven Hills Women's Health | Cincinnati | Ohio | 45231 | United States |
| Amy Brenner MD and Associates, LLC | Mason | Ohio | 45040 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| Allan Centre | Calgary | Alberta | T2J 7G9 | Canada |
| LaSalle Hospital | LaSalle | Quebec | H8P 1C1 | Canada |
| Hospital Universitario de la Universidad Autónoma de Nuevo Leon | Monterrey | Nuevo León | 66460 | Mexico |
| 32835865 | Derived | 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. |
| Known Month 12 Outcome |
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| 24 Month Visit Performed |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endometrial Cryoablation | Cerene(R) Cryotherapy Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Baseline PBLAC (Pictorial Blood Loss Assessment Chart) Score | 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. At baseline, the range of PBLAC values was 150.0 to 4506.5. | Mean | Standard Deviation | scores on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events | The Intent-to-Treat (ITT) population is comprised of all patients who successfully completed screening and presented on the day of treatment. | Posted | Number | Reports of events | 12 months |
|
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| ||||||||||||||||||||||||||||||||||
| 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. | The Intent-to-Treat (ITT) population comprised all patients who successfully completed screening and presented on the day of treatment. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 12 Months |
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| |||||||||||||||||||||||||||||||||||
| Secondary | Investigator Evaluation of the Uterine Cavity | Of 230 subjects with a known Month 12 outcome, 223 underwent a hysteroscopy at Month 12. The remaining seven (7) subjects encountered scheduling conflicts or illness. | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Investigator Assessment of Cavity Findings | Questions to the investigator | Investigators' assessment was based on the 204 subjects whose cavities could be fully visualized (see Secondary Outcome: Investigator Evaluation of the Uterine Cavity). | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Anesthesia and Pain Medications at Treatment | Posted | Count of Participants | Participants | Day of Treatment |
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| |||||||||||||||||||||||||||||||||||
| 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. | Some subjects did not provide a pain score rating due to sedation. One subject did not provide a pain score at her Day 1 visit. | Posted | Median | Full Range | units on a scale | Day of Treatment and Day One Post-Treatment |
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| Other Pre-specified | Subjects' Report of Their Last Menstrual Period | Subjects were asked to describe their last menstrual period | Posted | Count of Participants | Participants | 36 months |
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| Other Pre-specified | Menstrual Impact Questionnaire | Subjects' Report of Activity Limitations | Posted | Count of Participants | Participants | 36 months |
|
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| Other Pre-specified | Premenstrual Symptoms Impact Survey | Subjects' Report of Pre-Menstrual Symptoms (PMS) | Posted | Count of Participants | Participants | 36 months |
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| Other Pre-specified | Subject Satisfaction | Subject's level of satisfaction with the results of her Cerene treatment | Of 201 subjects who completed the study, 181 reported their level of satisfaction | Posted | Count of Participants | Participants | 36 Months |
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| ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Subject Recommendation | Subjects' reported level of recommendation to a friend/family | Of 201 subjects who completed the study, 193 reported their level of recommendation | Posted | Count of Participants | Participants | 36 months |
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| Other Pre-specified | Procedure Time | Device insertion to device removal | Posted | Mean | Standard Deviation | minutes | Day of Treatment |
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| Other Pre-specified | Return to Normal Daily Activities | Posted | Mean | Standard Deviation | days | Two-Weeks |
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36 Months
Adverse event information was collected throughout the study at each subject contact. All serious adverse events observed in the study are reported in "Serious Adverse Events" below. "Other (Not Including Serious) Adverse Events" below presents a summary of (1) for up to 12-month follow-up, device and/or procedure-related non-serious adverse events occurring in more than 1% of subjects and (2) for post 12-Month follow-up, all gynecologic adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Endometrial Cryoablation | Cerene(R) Cryotherapy Device | 0 | 242 | 6 | 242 | 29 | 242 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDra (20.1) | Systematic Assessment |
| |
| Acute Cholecystitis | Hepatobiliary disorders | MedDra (20.1) | Systematic Assessment |
| |
| Bile Duct Obstruction | Hepatobiliary disorders | MedDra (20.1) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | MedDra (20.1) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment |
| |
| Chronic Constipation | Gastrointestinal disorders | MedDra (20.1) | Systematic Assessment |
| |
| Paresthesia of limbs | Nervous system disorders | MedDra (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial vaginosis | Infections and infestations | MedDra (20.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDra (20.1) | Systematic Assessment |
| |
| Uterine cramps | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment |
| |
| Emesis | Gastrointestinal disorders | MedDra (20.1) | Systematic Assessment |
| |
| Fever | General disorders | MedDra (20.1) | Systematic Assessment |
| |
| Endometritis | Infections and infestations | MedDra (20.1) | Systematic Assessment |
| |
| Vulvovaginitis Streptococcal | Infections and infestations | MedDra (20.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDra (20.1) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDra (20.1) | Systematic Assessment |
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| Dyspareunia | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment |
| |
| Menstrual cramps | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment |
| |
| Uterine tenderness | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDra (20.1) | Systematic Assessment |
| |
| Adenomyosis | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
|
| Dysmenorrhea | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Dyspareunia | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Endometritis | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Intermenstrual bleeding | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Menorrhagia | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Pelvic cramping | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Pelvic pain | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Polycystic ovarian disease | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Pos- coital bleeding | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Pregnancy; uterine | Pregnancy, puerperium and perinatal conditions | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Pregnancy; uterine terminated | Pregnancy, puerperium and perinatal conditions | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Right breast mass | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Uterine fibroids | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Uterine prolapse Stage 2 | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Vaginal infection and/or discharge | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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| Vaginal/vulvar pruritus | Reproductive system and breast disorders | MedDra (20.1) | Systematic Assessment | Gynecologic adverse event reported after Month 12 |
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Investigators have the right to publish their data, with the following provisions: (1) investigators at academic centers have a time frame for submission of their manuscript, or other, to Sponsor prior to publication and (2) investigators at private clinics can request prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical and Regulatory Affairs | Channel Medsystems | 510-338-9301 | clinreg@channelmedsystems.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2016 | Apr 25, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
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| American Indian or Alaska Native |
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| Other |
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| Title | Denominators | Categories | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Denominators |
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| Categories |
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| Uterine cavity entry with a hysteroscope |
| |||||||
| Full visualization of the uterine cavity |
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| Title | Denominators | Categories |
|---|
| Would the Investigator be able to direct a biopsy anywhere within the uterine cavity? |
| |||||||
| Satisfied with ability to adequately visualize the endometrium to evaluate for pathologic change? |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Before Device Insertion |
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| After Device Insertion |
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| After Liner Deployment (before endometrial ablation was initiated) |
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| After 1 Minute of Ablation |
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| End of Ablation |
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| 15-30 Minutes Post-Procedure |
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| At Time of Discharge |
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| Day 1 |
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| Title | Measurements |
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