An interventional study of Cerene(R) Cryotherapy Device in Menorrhagia, sponsored by Channel Medsystems. Completed at 12 sites in 3 countries. Open to female participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Channel Medsystems · Not applicable, Interventional, and Treatment
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.
182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.
This study's enrollment of 242 is above the median of 100 across 133 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →Channel Medsystems is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Device: Cerene(R) Cryotherapy Device
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
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
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.
Time frame: 12 Months
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.
Time frame: 12 Months
Investigator Evaluation of the Uterine Cavity
Time frame: 12 Months
Investigator Assessment of Cavity Findings
Questions to the investigator
Time frame: 12 Months
Anesthesia and Pain Medications at Treatment
Time frame: 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.
Time frame: Day of Treatment and Day One Post-Treatment
Subjects' Report of Their Last Menstrual Period
Subjects were asked to describe their last menstrual period
Time frame: 36 months
Menstrual Impact Questionnaire
Subjects' Report of Activity Limitations
Time frame: 36 months
Premenstrual Symptoms Impact Survey
Subjects' Report of Pre-Menstrual Symptoms (PMS)
Time frame: 36 months
Subject Satisfaction
Subject's level of satisfaction with the results of her Cerene treatment
Time frame: 36 Months
Subject Recommendation
Subjects' reported level of recommendation to a friend/family
Time frame: 36 months
Procedure Time
Device insertion to device removal
Time frame: Day of Treatment
Return to Normal Daily Activities
Time frame: Two-Weeks
| Milestone | Endometrial Cryoablation |
|---|---|
| Started | 242 |
| Known month 12 outcome | 230 |
| 24 month visit performed | 210 |
| Completed | 201 |
| Not completed | 41 |
| Withdrew: Lost to follow-up | 13 |
| Withdrew: Intervention for menstrual bleeding | 17 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Pregnancy | 3 |
| Withdrew: Hysterectomy for fibroids | 2 |
| Withdrew: Hysterectomy for uterine prolapse | 1 |
| Withdrew: Iud: mirena | 1 |
| Reports of events | Endometrial Cryoablation |
|---|---|
| Serious adverse events | 7 |
| Serious device-related adverse events | 0 |
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.
| Participants | Endometrial Cryoablation |
|---|---|
| Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75 | 186 |
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.
| Participants | Endometrial Cryoablation |
|---|---|
| 0 - No symptom | 74 |
| 1 - Very Mild | 70 |
| 2 - Mild | 40 |
| 3 - Moderate | 33 |
| 4 - Severe | 10 |
| 5 - Very Severe | 3 |
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.
| Participants | Endometrial Cryoablation |
|---|---|
| Amenorrhea | 25 |
| Participants | Endometrial Cryoablation |
|---|---|
| Uterine cavity entry with a hysteroscope — YES | 220 |
| Uterine cavity entry with a hysteroscope — NO | 3 |
| Full visualization of the uterine cavity — YES | 204 |
| Full visualization of the uterine cavity — NO | 19 |
Questions to the investigator
| Participants | Endometrial Cryoablation |
|---|---|
| Would the Investigator be able to direct a biopsy anywhere within the uterine cavity? — YES | 178 |
| Would the Investigator be able to direct a biopsy anywhere within the uterine cavity? — NO | 26 |
| Satisfied with ability to adequately visualize the endometrium to evaluate for pathologic change? — YES | 195 |
| Satisfied with ability to adequately visualize the endometrium to evaluate for pathologic change? — NO | 9 |
| Participants | Endometrial Cryoablation |
|---|---|
| Paracervical block only | 20 |
| Paracervical block with nonsteroidal anti-inflammatories | 48 |
| Paracervical block with oral narcotics and/or anxiolytics | 167 |
| Paracervical block with intravenous sedation | 7 |
| General anesthesia | 0 |
Pain rating using numeric rating scale, minimum 0, maximum 10, with 0 designated as no pain and 10 designated as the worst pain.
| units on a scale | Endometrial Cryoablation |
|---|---|
| Before Device Insertion | 1 (0 to 10) |
| After Device Insertion | 2 (0 to 10) |
| After Liner Deployment (before endometrial ablation was initiated) | 1 (0 to 10) |
| After 1 Minute of Ablation | 2 (0 to 10) |
| End of Ablation | 1 (0 to 10) |
| 15-30 Minutes Post-Procedure | 2 (0 to 10) |
| At Time of Discharge | 2 (0 to 8) |
| Day 1 | 0 (0 to 8) |
Subjects were asked to describe their last menstrual period
| Participants | Endometrial Cryoablation |
|---|---|
| I no longer get my period | 29 |
| My periods are lighter than normal | 99 |
| My periods are normal | 50 |
| I continue to have heavy periods | 23 |
Subjects' Report of Activity Limitations
| Participants | Endometrial Cryoablation |
|---|---|
| Free of limitation in activity at moderate or higher level | 182 |
| Limitation in activity is present at moderate or higher level | 19 |
Subjects' Report of Pre-Menstrual Symptoms (PMS)
| Participants | Endometrial Cryoablation |
|---|---|
| Free of PMS often, most often, very often, or all of the time | 171 |
| PMS occur often, most often, very often, or all of the time | 30 |
Subject's level of satisfaction with the results of her Cerene treatment
| Participants | Endometrial Cryoablation |
|---|---|
| Satisfied or very satisfied | 153 |
| Dissatisfied or very dissatisfied | 28 |
Subjects' reported level of recommendation to a friend/family
| Participants | Endometrial Cryoablation |
|---|---|
| Definitely or maybe recommend | 175 |
| Probably not or definitely not recommend | 18 |
Device insertion to device removal
| minutes | Endometrial Cryoablation |
|---|---|
| Procedure Time | 6.9 ± 1.1 |
| days | Endometrial Cryoablation |
|---|---|
| Return to Normal Daily Activities | 2.0 ± 2.3 |
Collected over 36 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Endometrial Cryoablation | 0/242 (0%) | 6/242 (2.5%) | 29/242 (12%) |
| Event | Endometrial Cryoablation |
|---|---|
| Ectopic PregnancyPregnancy, puerperium and perinatal conditions | 1/242 |
| Acute CholecystitisHepatobiliary disorders | 1/242 |
| Bile Duct ObstructionHepatobiliary disorders | 1/242 |
| StrokeNervous system disorders | 1/242 |
| MenorrhagiaReproductive system and breast disorders | 1/242 |
| Chronic ConstipationGastrointestinal disorders | 1/242 |
| Paresthesia of limbsNervous system disorders | 1/242 |
| Event | Endometrial Cryoablation |
|---|---|
| MenorrhagiaReproductive system and breast disorders | 15/242 |
| Vaginal infection and/or dischargeReproductive system and breast disorders | 11/242 |
| Uterine crampsReproductive system and breast disorders | 8/242 |
| Bacterial vaginosisInfections and infestations | 7/242 |
| Pelvic painReproductive system and breast disorders | 4/242 |
| PresyncopeNervous system disorders | 3/242 |
| Urinary incontinenceRenal and urinary disorders | 2/242 |
| Menstrual crampsReproductive system and breast disorders | 2/242 |
| Pelvic painReproductive system and breast disorders | 2/242 |
| Vaginal dischargeReproductive system and breast disorders | 2/242 |
| Age, Continuous(years) | Endometrial Cryoablation |
|---|---|
| Mean | 40.1 ± 5.1 |
| Sex: Female, Male(Participants) | Endometrial Cryoablation |
|---|---|
| Female | 242 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Endometrial Cryoablation |
|---|---|
| White | 190 |
| Black or African American | 6 |
| American Indian or Alaska Native | 3 |
| Other | 43 |
| Baseline PBLAC (Pictorial Blood Loss Assessment Chart) Score(scores on a scale) | Endometrial Cryoablation |
|---|---|
| Mean | 360.6 ± 332.1 |
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