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Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Eclipse™ System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eclipse™ System | Device | The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System. |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Treatment Responders in the Intent to Treat (ITT) Cohort | Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Treatment Responders in the Per Protocol (PP) Population | Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline. | 3, 6 and 12 months |
| Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint - Number of Device Related Adverse Events | The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely). Events are classified as occurring either during fitting (the process of identifying the correct size of the device) or during treatment (defined as the time when a patient receives their long term wear device until the completion of the study). |
Abbreviated Inclusion Criteria:
Abbreviated Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Richter, PhD, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Massachusetts General Hospital (MGH) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25730213 | Background | Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D, Varma MG. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015 Mar;125(3):540-547. doi: 10.1097/AOG.0000000000000639. | |
| 30807411 | Derived | Richter HE, Dunivan G, Brown HW, Andy U, Dyer KY, Rardin C, Muir T, McNevin S, Paquette I, Gutman RE, Quiroz L, Wu J. A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence. Female Pelvic Med Reconstr Surg. 2019 Mar/Apr;25(2):113-119. doi: 10.1097/SPV.0000000000000681. |
| Label | URL |
|---|---|
| A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence (results of the LIFE Study) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | All patients fit with the device, including patients that did not enter treatment. All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. 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 | |||||
|---|---|---|---|---|---|---|---|
| Fitting |
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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 | Feb 9, 2017 | Apr 26, 2019 |
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Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score. St. Mark's is a validated scale widely used in fecal incontinence research. The scale has a 24 point range where 0 = total fecal continence (better outcome) and 24 = total fecal incontinence (worse outcome). A reduction in the St. Mark's score is a better outcome. |
| 12 months |
| Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline | Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score. The FIQoL scale asks a number of Fecal Incontinence (FI) related questions. Patient responses are rated from 1 to 4 points except one question which is rated from 1 to 5 points. The questions fall into four subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. The score for each subscale is the average of the responses in that group. For depression/self-perception the subscale score is from 1.0 to 5.0. The other subscale scores are from 1.0 to 4.0. The total FIQoL score is the sum of all four subscales, ranging from 4 to 17. For each subscale and the combined score, lower values indicate worse quality of life and higher values indicate better quality of life. An increase in score as compared to Baseline is therefore a better outcome. | 12 months |
| Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | The Patient Global Impression of Improvement (PGI-I) is a scale which describes the patient's perception of how their symptoms have change from Baseline. The scale has a range of 7 points from 1 to 7, where 1 = very much better than Baseline and 7 = very much worse than Baseline and 4 = no change from Baseline. A score below 4 is a better outcome and a score above 4 is a worse outcome, and a score of 4 is a neutral outcome. Note that because the patient is being asked to compare their symptoms to Baseline, no data is taken for this scale at Baseline and the score is an absolute value, not a change from a previous score. | 3, 6, 9 and 12 months |
| 3, 6, 9 and 12 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| University of North Carolina | Raleigh | North Carolina | 27607 | United States |
| Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Brown University (WIHRI) | Providence | Rhode Island | 02903 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Providence Sacred Heart | Spokane | Washington | 99204 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| 28734829 | Derived | Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects who completed the fitting process and entered the treatment period comprised the Intent-to-treat population. 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. |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Number | participants |
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| Previous Gynecological Surgeries/Treatments | Count of Participants | Participants |
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| Sexual Activity | Count of Participants | Participants |
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| Parity | Mean | Standard Deviation | Pregnancies |
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| Menopausal Status | Count of Participants | Participants |
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| Lower Urinary Tract and Bowel Conditions | Count of Participants | Participants |
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| Duration of Fecal Incontinence Symptoms | Count of Participants | Participants |
| |||||||||||||||||||||||
| Frequency of FI Symptoms (2 week period) | Mean | Standard Deviation | count |
| ||||||||||||||||||||||
| Subjects with Fecal Urgency | Count of Participants | Participants |
| |||||||||||||||||||||||
| Parity (Median) | Median | Full Range | Pregnancies |
| ||||||||||||||||||||||
| Frequency of FI Symptoms (2 week period) (median) | Median | Full Range | count |
|
| 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 | Count of Treatment Responders in the Intent to Treat (ITT) Cohort | Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline. | Posted | Count of Participants | Participants | 3 months |
|
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| |||||||||||||||||||||||||||
| Secondary | Count of Treatment Responders in the Per Protocol (PP) Population | Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline. | Posted | Count of Participants | Participants | 3, 6 and 12 months |
| |||||||||||||||||||||||||||||
| Secondary | Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline | Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score. St. Mark's is a validated scale widely used in fecal incontinence research. The scale has a 24 point range where 0 = total fecal continence (better outcome) and 24 = total fecal incontinence (worse outcome). A reduction in the St. Mark's score is a better outcome. | Posted | Mean | Standard Deviation | Score on a Scale | 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline | Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score. The FIQoL scale asks a number of Fecal Incontinence (FI) related questions. Patient responses are rated from 1 to 4 points except one question which is rated from 1 to 5 points. The questions fall into four subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. The score for each subscale is the average of the responses in that group. For depression/self-perception the subscale score is from 1.0 to 5.0. The other subscale scores are from 1.0 to 4.0. The total FIQoL score is the sum of all four subscales, ranging from 4 to 17. For each subscale and the combined score, lower values indicate worse quality of life and higher values indicate better quality of life. An increase in score as compared to Baseline is therefore a better outcome. | Posted | Mean | Standard Deviation | Score on a scale | 12 months |
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| Secondary | Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | The Patient Global Impression of Improvement (PGI-I) is a scale which describes the patient's perception of how their symptoms have change from Baseline. The scale has a range of 7 points from 1 to 7, where 1 = very much better than Baseline and 7 = very much worse than Baseline and 4 = no change from Baseline. A score below 4 is a better outcome and a score above 4 is a worse outcome, and a score of 4 is a neutral outcome. Note that because the patient is being asked to compare their symptoms to Baseline, no data is taken for this scale at Baseline and the score is an absolute value, not a change from a previous score. | Posted | Count of Participants | Participants | 3, 6, 9 and 12 months |
| |||||||||||||||||||||||||||||
| Other Pre-specified | Safety Endpoint - Number of Device Related Adverse Events | The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely). Events are classified as occurring either during fitting (the process of identifying the correct size of the device) or during treatment (defined as the time when a patient receives their long term wear device until the completion of the study). | Posted | Number | Count of Adverse Events | 3, 6, 9 and 12 months |
|
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Events were collected for the full duration of study, including the fitting and treatment periods, for a total participation of 3.5-15 months (typically 13 months). For further detail, the fitting period, which occurs first, requires 2-4 weeks, but can be repeated up to 3 times, for a total of 2-12 weeks in this phase (typically 4 weeks). The treatment period, which follows the fitting period, is a minimum of 3 months and up to 12 months (typically 12 months).
No difference in definitions. Adverse Event Categories: The majority of specific adverse events in this study occurred with very low frequency, which would not exceed common reporting thresholds. In order to provide a more accurate impression of the patient risk and to be more conservative in reporting, these low frequency events were gathered into groups by their systemic impact.
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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 | Fitting | All subjects who underwent the fitting process (interacted with a device), including those who did not enter the treatment period. The fitting process involved an office visit with a pelvic exam, followed by test fittings of the device to determine the correct size. Patients who were successfully fit then took home the Trial Insert device and wore it during the 2 weeks during which they collected diary data (logging bowel movements and incontinence episodes). This trial wear period was allowed to be extended due to scheduling or if the patient chose not to use the device during their menstrual cycle. Patients who did not achieve a successful fit were allowed to change device size and repeat the trial period up to 2 additional times (for a total of 3 fitting cycles). | 0 | 137 | 0 | 137 | 62 | 137 |
| EG001 | Treatment | All subjects who were successfully fit and completed their eligibility diary and who entered the 12 month treatment period. This includes patients who did not complete treatment. In treatment, subjects wore the Eclipse Insert and inflated it 3x per day using the provided Pump. Patients could remove and reinsert the device as needed for cleaning or pelvic rest. | 0 | 73 | 8 | 73 | 28 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment | Not device related. Patient hospitalized for chest pain, underwent heart catheterization. |
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| Suicidal ideations | Psychiatric disorders | Systematic Assessment | Not device related. |
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| Breast cancer | Reproductive system and breast disorders | Systematic Assessment | Not device related. |
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| Acute stroke | Nervous system disorders | Systematic Assessment | Not device related. |
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| Chest discomfort | Cardiac disorders | Systematic Assessment | Not device related. Worsening dyspnea on exertion. Cardiac catheter and stent placement. History of coronary artery disease. |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not device related. History of interstitial lung disease. |
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| Bradycardia | Cardiac disorders | Systematic Assessment | Not device related. |
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| Worsening degenerative joint disease | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not device related. Worsening degenerative joint disease of bilateral hips. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal Mucosal Wall Injury | Reproductive system and breast disorders | Systematic Assessment | Abrasion, bleeding, erythema, petechia, ecchymosis, hyperemia, or erosion of vaginal tissue apparent during pelvic examination. |
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| Lower Urinary Tract Issues | Reproductive system and breast disorders | Systematic Assessment | New or increased urinary incontinence or voiding difficulty or urinary frequency, urinary tract infections, or dysuria. |
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| Vaginal/Pelvic Discomfort/Irritation | Reproductive system and breast disorders | Systematic Assessment | Vaginal/Pelvic discomfort, pain, irritation, discharge, odor, burning sensation, or itching. |
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| Vaginal Infections | Reproductive system and breast disorders | Systematic Assessment | Yeast infection of the vagina or unspecified vaginitis. Does not include systemic yeast infections or infections of other areas that do not affect the vagina. |
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| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment | Leg pain. |
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| Constipation | Gastrointestinal disorders | Systematic Assessment | Constipation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Management | Pelvalon | 650-276-0130 | steve@pelvalon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2018 | Apr 26, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Hispanic or Latino |
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| 25 to <30 kg/m^2 |
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| >=30 kg/m^2 |
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| Prior urinary incontinence surgery |
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| Gallbladder removal (Cholecystectomy) |
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| Fistula repair |
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| None of these |
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| Post-menopause |
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| Irritable Bowel Syndrome (IBS) |
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| Participants |
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| OG002 | Per Protocol - 9 Months | Per Protocol cohort - 9 months is defined as all subjects who completed 9 months of the study without any major protocol deviations. 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. |
| OG003 | Per Protocol - 12 Months | Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations. |
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