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

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Menorrhagia
Intervention Device: Cerene(R) Cryotherapy Device
Enrollment 242
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description Cerene(R) Cryotherapy Device
Period Title: Overall Study
Started 242 [1]
Known Month 12 Outcome 230
24 Month Visit Performed 210
Completed 201 [2]
Not Completed 41
Reason Not Completed
Lost to Follow-up             13
Intervention for menstrual bleeding             17
Withdrawal by Subject             4
Pregnancy             3
Hysterectomy for fibroids             2
Hysterectomy for uterine prolapse             1
IUD: Mirena             1
[1]
Treated
[2]
36 Month Visit Completed
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description Cerene(R) Cryotherapy Device
Overall Number of Baseline Participants 242
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 242 participants
40.1  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 242 participants
Female
242
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 242 participants
White
190
  78.5%
Black or African American
6
   2.5%
American Indian or Alaska Native
3
   1.2%
Other
43
  17.8%
Baseline PBLAC (Pictorial Blood Loss Assessment Chart) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 242 participants
360.6  (332.1)
[1]
Measure Description:

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.

1.Primary Outcome
Title Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population is comprised of all patients who successfully completed screening and presented on the day of treatment.
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 242
Measure Type: Number
Unit of Measure: Reports of events
Serious adverse events 7
Serious device-related adverse events 0
2.Primary Outcome
Title Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75
Hide Description

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.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-Treat (ITT) population comprised all patients who successfully completed screening and presented on the day of treatment.
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 242
Measure Type: Count of Participants
Unit of Measure: Participants
186
  76.9%
3.Secondary Outcome
Title Dysmennorhea
Hide Description 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.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 230
Measure Type: Count of Participants
Unit of Measure: Participants
0 - No symptom
74
  32.2%
1 - Very Mild
70
  30.4%
2 - Mild
40
  17.4%
3 - Moderate
33
  14.3%
4 - Severe
10
   4.3%
5 - Very Severe
3
   1.3%
4.Secondary Outcome
Title Amenorrhea
Hide Description

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.

Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 242
Measure Type: Count of Participants
Unit of Measure: Participants
25
  10.3%
5.Secondary Outcome
Title Investigator Evaluation of the Uterine Cavity
Hide Description [Not Specified]
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 223
Measure Type: Count of Participants
Unit of Measure: Participants
Uterine cavity entry with a hysteroscope YES
220
  98.7%
NO
3
   1.3%
Full visualization of the uterine cavity YES
204
  91.5%
NO
19
   8.5%
6.Secondary Outcome
Title Investigator Assessment of Cavity Findings
Hide Description Questions to the investigator
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Investigators' assessment was based on the 204 subjects whose cavities could be fully visualized (see Secondary Outcome: Investigator Evaluation of the Uterine Cavity).
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 204
Measure Type: Count of Participants
Unit of Measure: Participants
Would the Investigator be able to direct a biopsy anywhere within the uterine cavity? YES
178
  87.3%
NO
26
  12.7%
Satisfied with ability to adequately visualize the endometrium to evaluate for pathologic change? YES
195
  95.6%
NO
9
   4.4%
7.Secondary Outcome
Title Anesthesia and Pain Medications at Treatment
Hide Description [Not Specified]
Time Frame Day of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 242
Measure Type: Count of Participants
Unit of Measure: Participants
Paracervical block only
20
   8.3%
Paracervical block with nonsteroidal anti-inflammatories
48
  19.8%
Paracervical block with oral narcotics and/or anxiolytics
167
  69.0%
Paracervical block with intravenous sedation
7
   2.9%
General anesthesia
0
   0.0%
8.Secondary Outcome
Title Subject Rating of Pain During Treatment and Day One Post-Treatment
Hide Description Pain rating using numeric rating scale, minimum 0, maximum 10, with 0 designated as no pain and 10 designated as the worst pain.
Time Frame Day of Treatment and Day One Post-Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 242
Median (Full Range)
Unit of Measure: units on a scale
Before Device Insertion Number Analyzed 241 participants
1
(0 to 10)
After Device Insertion Number Analyzed 240 participants
2
(0 to 10)
After Liner Deployment (before endometrial ablation was initiated) Number Analyzed 240 participants
1
(0 to 10)
After 1 Minute of Ablation Number Analyzed 240 participants
2
(0 to 10)
End of Ablation Number Analyzed 239 participants
1
(0 to 10)
15-30 Minutes Post-Procedure Number Analyzed 242 participants
2
(0 to 10)
At Time of Discharge Number Analyzed 242 participants
2
(0 to 8)
Day 1 Number Analyzed 241 participants
0
(0 to 8)
9.Other Pre-specified Outcome
Title Subjects' Report of Their Last Menstrual Period
Hide Description Subjects were asked to describe their last menstrual period
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 201
Measure Type: Count of Participants
Unit of Measure: Participants
I no longer get my period
29
  14.4%
My periods are lighter than normal
99
  49.3%
My periods are normal
50
  24.9%
I continue to have heavy periods
23
  11.4%
10.Other Pre-specified Outcome
Title Menstrual Impact Questionnaire
Hide Description Subjects' Report of Activity Limitations
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 201
Measure Type: Count of Participants
Unit of Measure: Participants
Free of limitation in activity at moderate or higher level
182
  90.5%
Limitation in activity is present at moderate or higher level
19
   9.5%
11.Other Pre-specified Outcome
Title Premenstrual Symptoms Impact Survey
Hide Description Subjects' Report of Pre-Menstrual Symptoms (PMS)
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 201
Measure Type: Count of Participants
Unit of Measure: Participants
Free of PMS often, most often, very often, or all of the time
171
  85.1%
PMS occur often, most often, very often, or all of the time
30
  14.9%
12.Other Pre-specified Outcome
Title Subject Satisfaction
Hide Description Subject's level of satisfaction with the results of her Cerene treatment
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 201 subjects who completed the study, 181 reported their level of satisfaction
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 181
Measure Type: Count of Participants
Unit of Measure: Participants
Satisfied or very satisfied
153
  84.5%
Dissatisfied or very dissatisfied
28
  15.5%
13.Other Pre-specified Outcome
Title Subject Recommendation
Hide Description Subjects' reported level of recommendation to a friend/family
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 201 subjects who completed the study, 193 reported their level of recommendation
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 193
Measure Type: Count of Participants
Unit of Measure: Participants
Definitely or maybe recommend
175
  90.7%
Probably not or definitely not recommend
18
   9.3%
14.Other Pre-specified Outcome
Title Procedure Time
Hide Description Device insertion to device removal
Time Frame Day of Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 242
Mean (Standard Deviation)
Unit of Measure: minutes
6.9  (1.1)
15.Other Pre-specified Outcome
Title Return to Normal Daily Activities
Hide Description [Not Specified]
Time Frame Two-Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description:
Cerene(R) Cryotherapy Device
Overall Number of Participants Analyzed 242
Mean (Standard Deviation)
Unit of Measure: days
2.0  (2.3)
Time Frame 36 Months
Adverse Event Reporting Description 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.
 
Arm/Group Title Endometrial Cryoablation
Hide Arm/Group Description Cerene(R) Cryotherapy Device
All-Cause Mortality
Endometrial Cryoablation
Affected / at Risk (%)
Total   0/242 (0.00%)    
Hide Serious Adverse Events
Endometrial Cryoablation
Affected / at Risk (%) # Events
Total   6/242 (2.48%)    
Gastrointestinal disorders   
Chronic Constipation  1  1/242 (0.41%)  1
Hepatobiliary disorders   
Acute Cholecystitis  1  1/242 (0.41%)  1
Bile Duct Obstruction  1  1/242 (0.41%)  1
Nervous system disorders   
Stroke  1  1/242 (0.41%)  1
Paresthesia of limbs  1  1/242 (0.41%)  1
Pregnancy, puerperium and perinatal conditions   
Ectopic Pregnancy  1  1/242 (0.41%)  1
Reproductive system and breast disorders   
Menorrhagia  1  1/242 (0.41%)  1
1
Term from vocabulary, MedDra (20.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Endometrial Cryoablation
Affected / at Risk (%) # Events
Total   29/242 (11.98%)    
Gastrointestinal disorders   
Emesis  1  1/242 (0.41%)  1
General disorders   
Fever  1  1/242 (0.41%)  1
Infections and infestations   
Bacterial vaginosis  1  7/242 (2.89%)  7
Endometritis  1  1/242 (0.41%)  1
Vulvovaginitis Streptococcal  1  1/242 (0.41%)  1
Musculoskeletal and connective tissue disorders   
Groin pain  1  1/242 (0.41%)  1
Nervous system disorders   
Presyncope  1  3/242 (1.24%)  4
Pregnancy, puerperium and perinatal conditions   
Pregnancy; uterine  1 [1]  1/242 (0.41%)  1
Pregnancy; uterine terminated  1 [1]  1/242 (0.41%)  1
Renal and urinary disorders   
Urinary incontinence  1  2/242 (0.83%)  2
Reproductive system and breast disorders   
Uterine cramps  1  8/242 (3.31%)  8
Dyspareunia  1  1/242 (0.41%)  1
Menstrual cramps  1  2/242 (0.83%)  2
Pelvic pain  1  2/242 (0.83%)  2
Uterine tenderness  1  1/242 (0.41%)  1
Vaginal discharge  1  2/242 (0.83%)  2
Adenomyosis  1 [1]  1/242 (0.41%)  1
Dysmenorrhea  1 [1]  2/242 (0.83%)  2
Dyspareunia  1 [1]  1/242 (0.41%)  1
Endometritis  1 [1]  1/242 (0.41%)  1
Intermenstrual bleeding  1 [1]  2/242 (0.83%)  2
Menorrhagia  1 [1]  15/242 (6.20%)  15
Pelvic cramping  1 [1]  2/242 (0.83%)  2
Pelvic pain  1 [1]  4/242 (1.65%)  4
Polycystic ovarian disease  1 [1]  1/242 (0.41%)  1
Pos- coital bleeding  1 [1]  1/242 (0.41%)  1
Right breast mass  1 [1]  1/242 (0.41%)  1
Uterine fibroids  1 [1]  2/242 (0.83%)  2
Uterine prolapse Stage 2  1 [1]  1/242 (0.41%)  1
Vaginal infection and/or discharge  1 [1]  11/242 (4.55%)  11
Vaginal/vulvar pruritus  1 [1]  2/242 (0.83%)  2
Vascular disorders   
Hypertension  1  2/242 (0.83%)  2
1
Term from vocabulary, MedDra (20.1)
Indicates events were collected by systematic assessment
[1]
Gynecologic adverse event reported after Month 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical and Regulatory Affairs
Organization: Channel Medsystems
Phone: 510-338-9301
EMail: clinreg@channelmedsystems.com
Layout table for additonal information
Responsible Party: Channel Medsystems
ClinicalTrials.gov Identifier: NCT02842736    
Other Study ID Numbers: CIP-0101
First Submitted: July 21, 2016
First Posted: July 25, 2016
Results First Submitted: April 25, 2019
Results First Posted: June 6, 2019
Last Update Posted: January 5, 2021