Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT00894933
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2009-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Performance Evaluation of the AMS CONTINUUM™ Device
Sponsor:
Organization:
Raw JSON
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'Primary Health Care'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.olson2@bsci.com', 'phone': '952-930-6428', 'title': 'Laura Olson, Clinical Project Manager', 'organization': 'American Medical Systems'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected that occurred during placement, wearing of the CONTINUUM device and during the 6-month follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy', 'otherNumAtRisk': 31, 'otherNumAffected': 30, 'seriousNumAtRisk': 31, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Urinary Incontinence - De Novo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Pain/Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders'}, {'term': 'Pain/Discomfort - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General disorders'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Erectile Dysfunction - De Novo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Pain/Discomfort - Abdominal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Erectile Dysfunction - Worsening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary Tract Infection (UTI)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'False Passage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Perforation - Bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain/Discomfort - Back', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Abdominal Bloating/Gas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fluid Overload (Hypervolemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Actelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Bladder Spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Clot in catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Disease progession', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hemorrhoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Increased Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Kidney Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Light Headed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Tunnel Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Vasovagal Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bladder Neck Contracture/Outlet Obstruct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders'}], 'seriousEvents': [{'term': 'Excessive bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Bladder Neck Contracture/Outlet Obstruct', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Separation/Disruption of Anastomosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety - Infection That Requires IV Antibiotics or Re-hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'PRIMARY', 'title': 'Successful Device Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'title': 'Successful', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Not successful', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Device placement', 'description': 'Defined as the establishment of a water-tight anastomosis immediately post-Device placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted (i.e. treated subjects)'}, {'type': 'PRIMARY', 'title': 'Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'title': 'Successful removal at 21 days', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Device not effective', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-21 days post-Device placement', 'description': 'Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraoperative/Postoperative Parameters - Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '168.5', 'spread': '219.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Device placement', 'description': 'To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.', 'unitOfMeasure': 'cc', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'SECONDARY', 'title': 'Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'title': 'Successful removal at 7 - 10 days', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Successful removal at 14 days', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Successful removal at 21 day', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Disrupted anastomosis requiring surgical intervent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7-10 and 13 - 15 days post-Device placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with successful device placement'}, {'type': 'SECONDARY', 'title': 'Intraoperative/Postoperative Parameters - Total Device Placement Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '5.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Device placement', 'description': 'To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'SECONDARY', 'title': 'Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '142.8', 'spread': '34.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Device placement', 'description': 'To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'PRIMARY', 'title': 'Safety - Perforation of the Bowel or Bladder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'PRIMARY', 'title': 'Safety - Creation of a False Passage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'PRIMARY', 'title': 'Safety - Urinary Retention Requiring Catheterization Post-Device Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'PRIMARY', 'title': 'Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'PRIMARY', 'title': 'Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}, {'type': 'PRIMARY', 'title': 'Safety - Bladder Neck Contracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects in whom device placement was attempted'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Continuum', 'description': 'Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.\n\nCONTINUUM™: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Cancelled Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Did not meeting incl/excl criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Continuum Device', 'description': 'Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'spread': '7.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'spread': '3.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'History of smoking', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prostate size (g) via TRUS', 'classes': [{'categories': [{'measurements': [{'value': '33.7', 'spread': '7.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Male patients ≥ 40 years old indicated for radical prostatectomy'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2009-05-05', 'resultsFirstSubmitDate': '2017-01-22', 'studyFirstSubmitQcDate': '2009-05-05', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-22', 'studyFirstPostDateStruct': {'date': '2009-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety - Infection That Requires IV Antibiotics or Re-hospitalization', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.'}, {'measure': 'Successful Device Placement', 'timeFrame': 'At Device placement', 'description': 'Defined as the establishment of a water-tight anastomosis immediately post-Device placement.'}, {'measure': 'Functionally Adequate Vesico-urethral Anastomosis Within 21 Days Post-Device Placement in Subjects With Successful Device Placement', 'timeFrame': '7-21 days post-Device placement', 'description': 'Evaluated by the proportion of Subjects who have had a successful Device placement and developed a functionally adequate anastomosis within 21 days post procedure (i.e. minimal or no extravasation noted during post-placement)'}, {'measure': 'Safety - Perforation of the Bowel or Bladder', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.'}, {'measure': 'Safety - Creation of a False Passage', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.'}, {'measure': 'Safety - Urinary Retention Requiring Catheterization Post-Device Removal', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.'}, {'measure': 'Safety - Mechanical Failure, Extrusion, Erosion, or Migration of the Device Requiring Surgical or Medical Intervention', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.'}, {'measure': 'Safety - Separation/Disruption of the Anastomosis Requiring Corrective Intervention', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.'}, {'measure': 'Safety - Bladder Neck Contracture', 'timeFrame': 'At Device placement, Device removal, 4 weeks post-Device removal, 6 months post-Device removal', 'description': 'Safety of the device was evaluated by incidences of specific serious Device-related adverse complications that occurred during placement, wearing of the CONTINUUM device and during 6-month follow-up.'}], 'secondaryOutcomes': [{'measure': 'Intraoperative/Postoperative Parameters - Estimated Blood Loss', 'timeFrame': 'At Device placement', 'description': 'To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as blood loss.'}, {'measure': 'Extravasation During Post-placement Cystogram at Either the First or Second Device Removal Attempts', 'timeFrame': '7-10 and 13 - 15 days post-Device placement'}, {'measure': 'Intraoperative/Postoperative Parameters - Total Device Placement Time', 'timeFrame': 'At Device placement', 'description': 'To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of Device placement.'}, {'measure': 'Intraoperative/Postoperative Parameters - Total Radical Prostatectomy Operative Time', 'timeFrame': 'At Device placement', 'description': 'To assess short-term clinical outcomes of the Device in facilitating the vesico-urethral anastomosis following a radical prostatectomy such as length of RP procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'Radical Prostatectomy', 'Vesico-Urethral Anastomosis'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '1. To assess the safety of using the CONTINUUM™ device by monitoring the side effects and complications associated with the Device following a radical prostatectomy.\n2. To verify CONTINUUM™ device performance using updated CONTINUUM™ device design modifications, physician procedure guide and training methodology.', 'detailedDescription': 'Surgery is the main treatment for localized prostate cancer. The most common technique is a "radical prostatectomy," which involves removing the prostate gland, seminal vesicles and nearby lymph nodes. Radical prostatectomy is a major operation, most suitable for otherwise healthy men whose cancer does not appear to have spread.One of the most technically challenging aspects of this surgery is reconstruction of the interrupted urinary tract by hand suturing the bladder neck anastomosis, in which the bladder neck is sewn to the urethra after the prostate has been removed.\n\nCONTINUUM™ (study Device) is a surgical device intended to be used as part of the radical prostatectomy procedure. The Device facilitates approximation of the bladder neck and urethral stump by bringing together and holding the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs. CONTINUUM™ also approximates the bladder and urethral stump to minimize extravasation, while simultaneously providing a conduit for drainage of urine from the bladder while the anastomotic site heals.\n\nThe concept of the CONTINUUM™ device and the feasibility of its operation have been tested in animal and human studies. Pilot clinical studies in the United States (G060095) found that the majority of Subjects who received and were discharged with the Device demonstrated a water-tight vesico-urethral anastomosis at the first Device removal visit. Additionally, no unanticipated adverse device effects (UADEs) were reported. The intent of this study is to verify CONTINUUM™ device performance across a variety of US sites and physicians using updated CONTINUUM™ device design modifications and physician training methodology on Device implant and removal techniques prior to initiation of a randomized US Pivotal study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All males ≥ 40 years old who are indicated for a radical prostatectomy will be eligible to participate in the study.\n* The Subject is willing and able to return for study follow-up visits according to the protocol.\n* The Subject can be off diuretics and blood thinners for at least one week prior to surgery.\n\nExclusion Criteria:\n\n* If contraindicated for surgery\n* Inability to understand the study or a history of non-compliance with medical advice\n* Unwilling or unable to sign an Informed Consent Form (ICF)\n* Participation in another clinical trial\n* Previously implanted urological device\n* A history of Recurrent urinary tract infections (UTI)\n* A history of stricture disease\n* Prior invasive prostate treatments (e.g., TURP, TUIP, laser therapy, radiotherapy, cryotherapy)\n* Neurological disease with a history of bladder dysfunction (e.g., Parkinson's disease)\n* Uncontrolled insulin-dependent diabetes\n* Chemotherapy within the past 6 months\n* Non-topical steroid use within the past 6 months\n* History of connective tissue or autoimmune conditions\n* Compromised immune system\n* Allergy to nitinol, nickel, titanium or silicone\n* Body Mass Index greater than or equal to 30\n* American Society of Anesthesiologists Score of \\> 3\n* Prostate size greater than or equal to 50 grams as determined by TRUS"}, 'identificationModule': {'nctId': 'NCT00894933', 'briefTitle': 'Performance Evaluation of the AMS CONTINUUM™ Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Medical Systems'}, 'officialTitle': 'Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy', 'orgStudyIdInfo': {'id': 'PE0814'}, 'secondaryIdInfos': [{'id': 'G090011'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuum', 'description': 'Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.', 'interventionNames': ['Device: CONTINUUM™']}], 'interventions': [{'name': 'CONTINUUM™', 'type': 'DEVICE', 'otherNames': ['Anastomosis Device'], 'description': 'Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.', 'armGroupLabels': ['Continuum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Urology', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '14619', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Urology', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '19004', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Urologic Consultants of Southeastern Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology Clinics of North Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78205', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Urology San Antonio Research PA', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Naveen Kella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology San Antonio Research PA'}, {'name': 'John Libertino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahey Clinic Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Medical Systems', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}