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A prospective, open label post market registry to collect Patient Reported Outcomes in an online data capture registry, maintained by Pelvalon, of women with fecal incontinence exiting the LIBERATE study (NCT02428595) continuing to use the Eclipse System for bowel control.
All LIBERATE (NCT02428595) study participants who complete the 12 month visit will be invited to participate in the LIBERATE-PRO post market registry in an effort to obtain additional long term quality of life and economic data. Subjects will be sent an email with a link to the survey(s) or mailed printed surveys depending on chosen survey delivery option to be completed at 3, 6, 9, and 12 months.Baseline will be defined as the baseline value in the LIBERATE study, prior to the insertion of the Eclipse System.
The St. Mark's (Vaizey) Incontinence Severity Score will be used to assess the severity of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The composite score calculated from these questions reflects the severity of FI and ranges from 0 (complete continence) to 24 (complete incontinence). The change from baseline score will be calculated at each time point. The average change from baseline score, computed as the mean change from baseline across all completed assessments, will be calculated.
The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated.
The FIQOL (Fecal Incontinence Quality of Life Questionnaire will be completed at 12 months. The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated.
The Eclipse Experience feedback (questions related to perceptions of device comfort, satisfaction with usage and features, and impact on daily activities) will be collected at 3, 6, 9, and 12 months.
All outcomes will be summarized descriptively at each time point.
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| Measure | Description | Time Frame |
|---|---|---|
| The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score | The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months. | 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated. |
| Measure | Description | Time Frame |
|---|---|---|
| The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score | The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated. As higher numbers indicate higher function, a positive change is desirable. |
Inclusion Criteria:
Exclusion Criteria:
There are no specific exclusions as this is a data collection registry on a commercially approved product
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Subjects exiting the LIBERATE study who are continuing to use the Eclipse System. Since all of the women in the prior LIBERATE study had to be over the age of 19 to participate in it, this means that all subjects in the registry will be over the age of 19 by default. For information about the LIBERATE study including inclusion/exclusion criteria please see NCT02428595.
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| Name | Affiliation | Role |
|---|---|---|
| Gena Dunivan, MD | Pelvalon Inc.; University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pelvalon, Inc. | Sunnyvale | California | 94085 | United States |
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| Label | URL |
|---|---|
| LIBERATE Clinical Trials.gov listing | View source |
| Pelvalon, Eclipse manufacturer and Study Sponsor, website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest. Surveys were completed at 3, 6, 9, and 12 months during the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score | The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months. | The number analyzed for each time point is the number of participants who provided a survey. Some participants provided surveys for some but not all time points. | Posted | Mean | Standard Deviation | Score on a Scale | 3, 6, 9, and 12 months |
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Adverse events were reported for the entirety of the study, for 12 months of patient treatment. Data was collected for a total of 24 months across all patients.
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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 | All Subjects | Consists of patients who elected to continue treatment after the previous LIBERATE study (NCT02428595). All patients had therefore worn the device for at least 12 months prior to entering this study. In treatment, subjects wear the Eclipse Insert and inflate it 3x per day using the provided Pump. Patients can remove and reinsert the device as needed for cleaning or pelvic rest. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Management | Pelvalon | 650-276-0130 | steve@pelvalon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2019 | Jan 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D007410 | Intestinal Diseases |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 3, 6, 9, and 12 months |
| 12 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Menopausal Status | Count of Participants | Participants |
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| Secondary | Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score | The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated. | Posted | Count of Participants | Participants | 3, 6, 9, and 12 months |
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| Other Pre-specified | The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score | The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated. As higher numbers indicate higher function, a positive change is desirable. | Posted | Mean | Standard Deviation | Score on a scale | 12 months |
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| Much Better (2) |
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| A Little Better (3) |
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| No Change (4) |
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| A Little Worse (5) |
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| Much Worse (6) |
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| Very Much Worse (7) |
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| Change in Embarrassment Subscale score |
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