Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2026-02-20 @ 4:41 AM
Study NCT ID:
NCT04773106
Status:
COMPLETED
Last Update Posted:
2025-05-18
First Post:
2021-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical@implandata.com', 'phone': '+49 (0) 511 - 2204 2580', 'title': 'Clinical Study Manager', 'organization': 'Implandata Ophthalmic Products GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 360 to Day 1080 (V09 to V13). In Germany the term SAE is defined according to §2 Section 5 MPSV.', 'description': 'SAE defined as AE that\n\n1. Led to death\n2. Led to a serious deterioration in health of a subject that:\n\n a Resulted in life-threatening illness or injury b Resulted in permanent impairment of body-structure or function c Required in-patient hospitalization or prolongation of existing hospitalization d Required medical or surgical intervention to prevent permanent impairment to body-structure or a -function\n3. Led to foetal distress, foetal death or a congenital abnormality or birth defect', 'eventGroups': [{'id': 'EG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 13, 'seriousNumAtRisk': 22, 'deathsNumAffected': 1, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19 infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased intraocular pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased intraocular pressure -non-study eye-', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Bone fracture, upper arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac stent implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death, non-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenterological complaints', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization b/o nose surgery (removal of polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain and fluid accumulation in the abdominal cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleuritis sicca', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Performance: Level of Agreement Between GAT and the ARGOS-SC System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'measurements', 'counts': [{'value': '522', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-6.2', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'Level of Agreement between intraocular pressure (IOP) measurements made using GAT \\& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'measurements', 'denomUnitsSelected': 'measurements', 'populationDescription': 'All available GAT and ARGOS-SC measurements.'}, {'type': 'SECONDARY', 'title': 'Safety: Number of Patients Experiencing a Device-related SAE (SADE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'Number of patients experiencing a device-related SAE (SADE)', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'Total number of AEs', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'classes': [{'title': 'Overall number of AEs/ADEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}, {'units': 'Total number of AEs', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Overall number of AEs/ADEs affecting the study eye, of which', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}, {'units': 'Total number of AEs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'AEs related to medical procedure and/or', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'Total number of AEs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AEs related to medical device and/or', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'Total number of AEs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AEs related to other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}, {'units': 'Total number of AEs', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.', 'unitOfMeasure': 'A(D)Es', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Total number of AEs', 'denomUnitsSelected': 'Total number of AEs', 'populationDescription': 'A total of 50 AEs in 16 patients were reported in the ARGOS-SC follow-up study. In overall 15 adverse events were documented in 14 patients affecting the study eye. 12 out of 50 AEs in 7 patients fulfilled at least one criterion for "serious adverse event" (SAE) and were reported as such. All of these SAEs were unrelated to the medical device.'}, {'type': 'SECONDARY', 'title': 'Performance: Percentage of Measurements Within +/- 5 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}, {'units': 'comparisons', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'Concordance of the ARGOS-SC\\<\\>GAT measurement. Method applied: The probability distribution of the difference in the measurements made using GAT \\& the ARGOS-SC system per visit ("paired measurement") grouped within 1 mmHg was compared to the outcome measure of achieving 65% agreement of the total number of comparisons between +/-5 mmHg.', 'unitOfMeasure': 'percentage of comparisons', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'comparisons', 'denomUnitsSelected': 'comparisons', 'populationDescription': 'All available GAT\\<\\>ARGOS-SC comparisons.'}, {'type': 'SECONDARY', 'title': 'Performance: Device Malfunctions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'DDs', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'The number of observed device malfunctions / deficiencies (DDs) related to the ARGOS-SC system, consisting of the ARGOS-SC implant and an external handheld reader device for the activation, power supply, and readout of the implanted sensor.', 'unitOfMeasure': 'DDs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'DDs', 'denomUnitsSelected': 'DDs', 'populationDescription': 'Of the 22 patients, device deficiencies (all related to the Reader device (external handheld device)) have been documented for 10 patients, hence the 10 participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Usability: User Acceptance at the Investigational Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '3.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1080 (V13)', 'description': "User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of Investigator's questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). Overall Number of Participants Analyzed represents the 8 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The user acceptance questionnaire for physicians was collected from 8 investigators.'}, {'type': 'SECONDARY', 'title': 'Usability: User Acceptance at Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '3.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1080 (V13)', 'description': 'User acceptance of the ARGOS-SC system at home by means of evaluation of patient questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). The score 7 represents a greater user acceptance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each patient was asked to provide feedback on the user acceptance of the ARGOS-SC system at home. A total of 15 patients provided feedback via a structured questionnaire'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'comment': 'Of the 22 patients enrolled, three patients voluntarily withdrew from the study during the follow-up and one patient deceased for unrelated reasons.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment from December 2019 to February 2021 in medical clinics.', 'preAssignmentDetails': 'Of the ARGOS-SC01 subjects, 22 patients consented to the ARGOS-SC01 follow-up study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ARGOS-SC Sensor', 'description': 'ARGOS-SC pressure sensor previously implanted in the ARGOS-SC01 study during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery.\n\nARGOS-SC system: An active implantable intraocular pressure sensor implanted in the suprachoriodal space of the human eye, in combination with non-penetrating glaucoma surgery.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.0', 'spread': '10.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of Glaucoma', 'classes': [{'title': 'Primary open-angle glaucoma (POAG)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Ocular hypertension (OHT)/Glaucoma suspect', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Pseudoexfoliative (PEX) glauoma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All ARGOS-SC01 patients who have consented to the ARGOS-SC01 follow-up study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-27', 'size': 1334878, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-21T03:10', 'hasProtocol': True}, {'date': '2022-09-01', 'size': 2922091, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-21T03:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2021-02-21', 'resultsFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2021-02-24', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-24', 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance: Level of Agreement Between GAT and the ARGOS-SC System', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'Level of Agreement between intraocular pressure (IOP) measurements made using GAT \\& the ARGOS-SC system (IOP in mmHg) following the Bland-Altman method.'}], 'secondaryOutcomes': [{'measure': 'Safety: Number of Patients Experiencing a Device-related SAE (SADE)', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'Number of patients experiencing a device-related SAE (SADE)'}, {'measure': 'Safety: Incidence, Nature, Severity and Seriousness of Observed Adverse Events (AEs) and Adverse Device Events (ADEs)', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.'}, {'measure': 'Performance: Percentage of Measurements Within +/- 5 mmHg', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'Concordance of the ARGOS-SC\\<\\>GAT measurement. Method applied: The probability distribution of the difference in the measurements made using GAT \\& the ARGOS-SC system per visit ("paired measurement") grouped within 1 mmHg was compared to the outcome measure of achieving 65% agreement of the total number of comparisons between +/-5 mmHg.'}, {'measure': 'Performance: Device Malfunctions', 'timeFrame': 'Day 360 to Day 1080 (V09 to V13)', 'description': 'The number of observed device malfunctions / deficiencies (DDs) related to the ARGOS-SC system, consisting of the ARGOS-SC implant and an external handheld reader device for the activation, power supply, and readout of the implanted sensor.'}, {'measure': 'Usability: User Acceptance at the Investigational Site', 'timeFrame': 'Day 1080 (V13)', 'description': "User acceptance of the ARGOS-SC system at the investigational site by means of evaluation of Investigator's questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). Overall Number of Participants Analyzed represents the 8 physician investigators who completed the User Acceptance Questionnaire. The score 7 represents a greater user acceptance."}, {'measure': 'Usability: User Acceptance at Home', 'timeFrame': 'Day 1080 (V13)', 'description': 'User acceptance of the ARGOS-SC system at home by means of evaluation of patient questionnaires on a scale of 1 to 7 how strongly they agree to given statements (1 = totally disagree, 7 = totally agree). The score 7 represents a greater user acceptance.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-penetrating glaucoma surgery', 'Open angle glaucoma', 'Intraocular pressure measurements', 'Suprachoroidal pressure sensor', 'ARGOS-SC'], 'conditions': ['Glaucoma', 'Open Angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '39892748', 'type': 'RESULT', 'citation': 'Micheletti E, Mansouri K, Dick HB, Hoffmann EM, Mackert MJ, Weinreb RN, Szurman P; EYEMATE-SC Study Group. Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology. 2025 Jul;132(7):775-784. doi: 10.1016/j.ophtha.2025.01.021. Epub 2025 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and performance of the ARGOS-SC system.', 'detailedDescription': 'This study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. This study is a follow-up study to the ARGOS-SC01 study (NCT03756662). Patients who have graduated the ARGOS-SC01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). This study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this ARGOS-SC01\\_FU study.\n\nThe sensor was always implanted in one eye only which will be the study eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Subjects of the ARGOS-SC01 study with an implanted ARGOS-SC suprachoroidal pressure sensor.\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT04773106', 'briefTitle': 'Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Implandata Ophthalmic Products GmbH'}, 'officialTitle': 'Follow-up of the First in Man, Prospective, Open-label, Single Arm, Multicenter Clinical Investigation to Assess the Long-term Safety and Performance of the ARGOS-SC Suprachoroidal Pressure Sensor System in Patients With Glaucoma Underwent Non-penetrating Glaucoma Surgery (Follow-up Month 12 - Month 36)', 'orgStudyIdInfo': {'id': 'ARGOS-SC01_Follow-up'}, 'secondaryIdInfos': [{'id': 'CIV-19-11-030784', 'type': 'REGISTRY', 'domain': 'Eudamed'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ARGOS-SC Sensor', 'description': 'The ARGOS-SC sensor was already implanted in the earlier ARGOS-SC01 study.', 'interventionNames': ['Device: ARGOS-SC suprachoroidal pressure sensor']}], 'interventions': [{'name': 'ARGOS-SC suprachoroidal pressure sensor', 'type': 'DEVICE', 'otherNames': ['EYEMATE-SC'], 'description': 'The ARGOS-SC pressure sensor was additionally implanted during routine local intraocular pressure lowering procedures in patients with glaucoma undergoing non-penetrating glaucoma surgery in the earlier ARGOS-SC01 study.', 'armGroupLabels': ['ARGOS-SC Sensor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44892', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Universitäts-Augenklinik Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Augenklinik der LMU München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '66280', 'city': 'Sulzbach', 'country': 'Germany', 'facility': 'Knappschaftsklinikum Saar GmbH, Augenklinik Sulzbach', 'geoPoint': {'lat': 49.29882, 'lon': 7.05696}}, {'zip': '1006', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Swiss Glaucoma Research Foundation, Centre du Glaucome, Clinique Montchoisi', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Peter Szurman, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Knappschaftsklinikum Saar GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Implandata Ophthalmic Products GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CRO Dr. med Kottmann GmbH & Co. KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}