Ignite Creation Date:
2025-12-24 @ 1:55 PM
Ignite Modification Date:
2026-01-03 @ 11:05 PM
Study NCT ID:
NCT02428595
Status:
COMPLETED
Last Update Posted:
2019-09-24
First Post:
2015-04-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'steve@pelvalon.com', 'phone': '650-276-0130', 'title': 'Clinical Management', 'organization': 'Pelvalon'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '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).', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Fitting', 'description': '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).', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 62, 'seriousNumAtRisk': 137, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment', 'description': '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.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 28, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Vaginal Mucosal Wall Injury', 'notes': 'Abrasion, bleeding, erythema, petechia, ecchymosis, hyperemia, or erosion of vaginal tissue apparent during pelvic examination.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 46, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower Urinary Tract Issues', 'notes': 'New or increased urinary incontinence or voiding difficulty or urinary frequency, urinary tract infections, or dysuria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal/Pelvic Discomfort/Irritation', 'notes': 'Vaginal/Pelvic discomfort, pain, irritation, discharge, odor, burning sensation, or itching.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal Infections', 'notes': '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.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal discomfort', 'notes': 'Leg pain.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'notes': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest Pain', 'notes': 'Not device related. Patient hospitalized for chest pain, underwent heart catheterization.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideations', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute stroke', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'notes': 'Not device related. Worsening dyspnea on exertion. Cardiac catheter and stent placement. History of coronary artery disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Interstitial lung disease', 'notes': 'Not device related. History of interstitial lung disease.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'notes': 'Not device related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening degenerative joint disease', 'notes': 'Not device related. Worsening degenerative joint disease of bilateral hips.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 137, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Count of Treatment Responders in the Intent to Treat (ITT) Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent to Treat', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Count of patients with \\>50% reduction in the average number of FI episodes per week as compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Treatment Responders in the Per Protocol (PP) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol - 3 Months', 'description': 'Per Protocol cohort - 3 months is defined as all subjects who completed 3 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.'}, {'id': 'OG001', 'title': 'Per Protocol - 6 Months', 'description': 'Per Protocol cohort - 6 months is defined as all subjects who completed 6 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.'}, {'id': 'OG002', 'title': 'Per Protocol - 12 Months', 'description': 'Per Protocol cohort - 12 months is defined as all subjects who completed 12 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6 and 12 months', 'description': 'Count of patients with \\>50% reduction in the average number of FI episodes per week as compared to Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol - 12 Months', 'description': 'Per Protocol cohort - 12 months is defined as all subjects who completed 12 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'spread': '6.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': "Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score.\n\nSt. 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.", 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol - 12 Months', 'description': 'Per Protocol cohort - 12 months is defined as all subjects who completed 12 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.'}], 'classes': [{'title': 'Change in Lifestyle Subscale score', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Change in Coping/Behavior Subscale score', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Change in Depression/Self Perception Subscalescore', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change in Embarrassment Subscale score', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nAn increase in score as compared to Baseline is therefore a better outcome.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Per Protocol - 3 Months', 'description': 'Per Protocol cohort - 3 months is defined as all subjects who completed 3 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.'}, {'id': 'OG001', 'title': 'Per Protocol - 6 Months', 'description': 'Per Protocol cohort - 6 months is defined as all subjects who completed 6 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.'}, {'id': 'OG002', 'title': 'Per Protocol - 9 Months', 'description': '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.'}, {'id': 'OG003', 'title': 'Per Protocol - 12 Months', 'description': 'Per Protocol cohort - 12 months is defined as all subjects who completed 12 months of the study without any major protocol deviations.'}], 'classes': [{'title': 'Very Much Better', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}, {'title': 'Much Better', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'A Little Better', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'A Little Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6, 9 and 12 months', 'description': "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.\n\nThe 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.\n\nNote 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.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Endpoint - Number of Device Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '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.'}, {'id': 'OG001', 'title': 'Fitting', 'description': 'The period of time where a patient is fitted with the device in order to determine the correct size. All patients in the Treatment group are also present in the Fitting group. Adverse events which occurred in the Treatment phase are not included here.'}], 'classes': [{'title': 'Non-serious adverse events (device related)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events (device related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3, 6, 9 and 12 months', 'description': 'The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely).\n\nEvents 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).', 'unitOfMeasure': 'Count of Adverse Events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients', 'description': '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.'}], 'periods': [{'title': 'Fitting', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': '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.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.3', 'spread': '11.51', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'title': '<18.5 kg/m^2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '18.5 to <25 kg/m^2', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': '25 to <30 kg/m^2', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': '>=30 kg/m^2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous Gynecological Surgeries/Treatments', 'classes': [{'title': 'Hysterectomy', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Prior prolapse surgery (excluding hysterectomy)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Prior urinary incontinence surgery', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Gallbladder removal (Cholecystectomy)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Fistula repair', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'None of these', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sexual Activity', 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Pregnancies', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Menopausal Status', 'classes': [{'title': 'Pre-menopause', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Peri-menopause', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Post-menopause', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lower Urinary Tract and Bowel Conditions', 'classes': [{'title': 'Urinary incontinence', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Overactive bladder (urinary frequency)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}, {'title': 'Irritable Bowel Syndrome (IBS)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Fecal Incontinence Symptoms', 'classes': [{'title': '6 months-5 years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': '>5 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Frequency of FI Symptoms (2 week period)', 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '12.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'count', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjects with Fecal Urgency', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity (Median)', 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Pregnancies', 'dispersionType': 'FULL_RANGE'}, {'title': 'Frequency of FI Symptoms (2 week period) (median)', 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'count', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-09', 'size': 839803, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-26T13:45', 'hasProtocol': True}, {'date': '2018-04-02', 'size': 554140, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-26T13:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 137}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-30', 'studyFirstSubmitDate': '2015-04-18', 'resultsFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2015-04-27', 'lastUpdatePostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-30', 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Endpoint - Number of Device Related Adverse Events', 'timeFrame': '3, 6, 9 and 12 months', 'description': 'The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely).\n\nEvents 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).'}], 'primaryOutcomes': [{'measure': 'Count of Treatment Responders in the Intent to Treat (ITT) Cohort', 'timeFrame': '3 months', 'description': 'Count of patients with \\>50% reduction in the average number of FI episodes per week as compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Count of Treatment Responders in the Per Protocol (PP) Population', 'timeFrame': '3, 6 and 12 months', 'description': 'Count of patients with \\>50% reduction in the average number of FI episodes per week as compared to Baseline.'}, {'measure': "Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline", 'timeFrame': '12 months', 'description': "Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score.\n\nSt. 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."}, {'measure': 'Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline', 'timeFrame': '12 months', 'description': 'Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nAn increase in score as compared to Baseline is therefore a better outcome.'}, {'measure': 'Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores', 'timeFrame': '3, 6, 9 and 12 months', 'description': "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.\n\nThe 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.\n\nNote 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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fecal Incontinence']}, 'referencesModule': {'references': [{'pmid': '25730213', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30807411', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '28734829', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://journals.lww.com/greenjournal/Citation/2015/03000/A_Vaginal_Bowel_Control_System_for_the_Treatment.3.aspx', 'label': 'A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence (results of the LIFE Study)'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Abbreviated Inclusion Criteria:\n\n* History of Fecal Incontinence (FI) for at least 6 months\n* Subject willing and able to give written informed consent to participate in the study\n* Subject can read, write and communicate fluently in English\n* Subject willing and able to comply with visit schedule\n* Subject is able to physically manage the insertion and removal of the Insert\n\nAbbreviated Exclusion Criteria:\n\n* Vaginal childbirth within the last 18 months\n* Currently pregnant or planning pregnancy during the study period\n* Acute infections or genito-urinary injuries that would impact comfortable device use\n* Current treatment for Fecal Incontinence other than medical management\n* Removal or diversion of any portion of the bowel\n* Recent urogenital or colorectal surgeries\n* Chronic abdominal pain in absence of diarrhea\n* Chronic (\\>6 mos) rectal, anal or pelvic pain\n* Chronic watery diarrhea, unmanageable by drugs or diet\n* Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis\n* Rectal prolapse (mucosal or full thickness)\n* Grade III or IV hemorrhoids\n* Pelvic organ prolapse beyond the plane of the hymen\n* Concurrent use of intra-vaginal pessary or other device\n* Anal or pelvic malignancy within last 5 years\n* History of pelvic irradiation for cancer\n* Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk"}, 'identificationModule': {'nctId': 'NCT02428595', 'acronym': 'LIBERATE', 'briefTitle': 'A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pelvalon, Inc.'}, 'officialTitle': 'A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women', 'orgStudyIdInfo': {'id': 'CA005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Eclipse™ System', 'interventionNames': ['Device: Eclipse™ System']}], 'interventions': [{'name': 'Eclipse™ System', 'type': 'DEVICE', 'otherNames': ['Vaginal Bowel Control (VBC) Therapy'], 'description': '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.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital (MGH)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown University (WIHRI)', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Sacred Heart', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Holly Richter, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pelvalon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}