Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT05198518
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2022-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Microcurrent Device (TIVIC Health)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alfred-marc.iloreta@mountsinai.org', 'phone': '(212) 241-9410', 'title': 'Alfred Marc C Iloreta Jr, MD', 'organization': 'Icahn School of Medicine at Mount Sinai'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '21 days', 'eventGroups': [{'id': 'EG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Pain Visual Analog Score After First Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.31', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure', 'description': 'Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Pain Visual Analog Score After Second Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure', 'description': 'Change in postoperative pain score after second use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the second time they use the device.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Pain Visual Analog Score After Third Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.7', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.05', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '2.47', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.84', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure', 'description': 'Change in postoperative pain score after third use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the third time they use the device.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Pain Visual Analog Score After Fourth Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure', 'description': 'Change in postoperative pain score after fourth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fourth time they use the device.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Pain Visual Analog Score After Fifth Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '2.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure', 'description': 'Change in postoperative pain score after fifth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fifth time they use the device.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Sino-Nasal Outcome Test (SNOT 22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '46.5', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '37.6', 'spread': '21.8', 'groupId': 'OG001'}]}]}, {'title': '2 weeks post-op', 'categories': [{'measurements': [{'value': '27.0', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '15.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 weeks Post-Op', 'description': 'The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 2 weeks Post-Op', 'description': 'Full scale from 0-100. Higher score indicates more severe symptoms', 'unitOfMeasure': 'mean difference in score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Debridement Associated Pain Visual Analog Score Before Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.88', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.68', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '4.71', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.31', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '4', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '3.71', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '3.85', 'spread': '2.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Debridement Associated Pain Visual Analog Score After First Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.47', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '5.67', 'spread': '2.99', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '3.76', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '5', 'spread': '2.62', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '3.59', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '3.59', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the first use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Debridement Associated Pain Visual Analog Score After Second Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.71', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '3.05', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '4.29', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.25', 'spread': '2.47', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '1.82', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '3.71', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the second use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Debridement Associated Pain Visual Analog Score After Third Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.4', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '4.11', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '3.33', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '3.13', 'spread': '1.85', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the third use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Debridement Associated Pain Visual Analog Score After Fourth Use of Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.75', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '3.33', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': '2 hour', 'categories': [{'measurements': [{'value': '3.41', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': '4 hour', 'categories': [{'measurements': [{'value': '2.91', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '2.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the fourth use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'OG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'classes': [{'title': 'Tylenol', 'categories': [{'measurements': [{'value': '24.3', 'spread': '30.83', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '14.87', 'groupId': 'OG001'}]}]}, {'title': 'Oxy', 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily until 2nd postoperative visit (day 14)', 'description': 'Participants will record their postoperative pain medication daily usage (opioids and acetaminophen). Number of Acetaminophen 325mg or Number of Oxycodone 5 mg taken across 2 weeks post-op', 'unitOfMeasure': 'number of pills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants Screened', 'description': 'Participants consented and had screening visit to determine eligibility'}, {'id': 'FG001', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'FG002', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}], 'periods': [{'title': 'Screening Visit', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Deemed unable to participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Enrolled Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '60 patients met the inclusion criteria and enrolled into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Microcurrent TENS Device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region\n\nMicrocurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.'}, {'id': 'BG001', 'title': 'Sham Device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.\n\nSham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.38', 'spread': '14.63', 'groupId': 'BG000'}, {'value': '39.55', 'spread': '14.31', 'groupId': 'BG001'}, {'value': '40.35', 'spread': '14.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White (Caucasian)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Sinus Surgery', 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Pre-Operative Diagnosis', 'classes': [{'title': 'Chronic Rhinosinusitis without Polyposis', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Rhinosinusitis with Polyposis', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Septoplasty', 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-22', 'size': 441121, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-12T15:48', 'hasProtocol': True}, {'date': '2023-11-09', 'size': 367508, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-12T15:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participant and all study staff will be blinded to which device they are receiving, either the study device or the identical sham device. Devices will be labeled A or B, with only the device manufacturer knowing which device is the active study device and which is the sham.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomly assigned in a 1:1 ratio to receive the intervention or placebo. Randomization will be completed via a computer-generated randomization table.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2022-01-06', 'resultsFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-27', 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Visual Analog Score After First Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure', 'description': 'Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device.'}, {'measure': 'Change in Pain Visual Analog Score After Second Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure', 'description': 'Change in postoperative pain score after second use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the second time they use the device.'}, {'measure': 'Change in Pain Visual Analog Score After Third Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure', 'description': 'Change in postoperative pain score after third use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the third time they use the device.'}, {'measure': 'Change in Pain Visual Analog Score After Fourth Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure', 'description': 'Change in postoperative pain score after fourth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fourth time they use the device.'}, {'measure': 'Change in Pain Visual Analog Score After Fifth Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure', 'description': 'Change in postoperative pain score after fifth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.\n\nParticipants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fifth time they use the device.'}, {'measure': 'Sino-Nasal Outcome Test (SNOT 22)', 'timeFrame': 'Baseline and 2 weeks Post-Op', 'description': 'The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden.'}, {'measure': 'Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score', 'timeFrame': 'Baseline and 2 weeks Post-Op', 'description': 'Full scale from 0-100. Higher score indicates more severe symptoms'}], 'secondaryOutcomes': [{'measure': 'Debridement Associated Pain Visual Analog Score Before Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.'}, {'measure': 'Debridement Associated Pain Visual Analog Score After First Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the first use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.'}, {'measure': 'Debridement Associated Pain Visual Analog Score After Second Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the second use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.'}, {'measure': 'Debridement Associated Pain Visual Analog Score After Third Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the third use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.'}, {'measure': 'Debridement Associated Pain Visual Analog Score After Fourth Use of Device', 'timeFrame': 'baseline, 10 min, 2 hour, 4 hour on POD14', 'description': 'Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the fourth use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.'}, {'measure': 'Postoperative Pain Medication Usage', 'timeFrame': 'Daily until 2nd postoperative visit (day 14)', 'description': 'Participants will record their postoperative pain medication daily usage (opioids and acetaminophen). Number of Acetaminophen 325mg or Number of Oxycodone 5 mg taken across 2 weeks post-op'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['chronic rhinosinusitis', 'postoperative pain', 'microcurrent'], 'conditions': ['Chronic Rhinosinusitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). This study is a prospective randomized controlled study. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation study device or a sham device that appears identical to the active device while emitting no therapeutic microcurrent. Subjects will self-treat with the device at home and will be followed for 2 weeks after FESS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled for FESS functional nasal or endoscopic sinus surgery\n* Possessing an American Society of Anesthesiologists physical status classification of I or II\n* Age ≥ 18\n* Possess the capacity to give informed consent\n* Able to read, write and understand English or Spanish\n* Able to attend follow up visits at postop days 7 and 14 Visit 1 (within 0 - day 14) and post-op Visit 2 (within 10 - 21 days)\n* Postop pain VAS ≥ 5 in PACU phase II\n\nExclusion Criteria:\n\n* Age \\< 18\n* Does not understand English or Spanish\n* Does not meet inclusion criteria\n* History of chronic pain\n* Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain management specialists\n* Neurologic disorders (including seizure disorders)\n* Undergoing planned or unplanned additional procedures at the time of FESS surgery\n* In custody of the state\n* Prisoners\n* Known to be pregnant\n* Implanted cranial metallic components or devices including deep brain stimulators or cochlear implants\n* Has an implanted or external worn cardiac device including pacemakers, automated implantable cardioverter defibrillator (AICD), or any other cardiac electric devices (including non-implanted devices, e.g. defibrillator vest)'}, 'identificationModule': {'nctId': 'NCT05198518', 'briefTitle': 'Microcurrent Device (TIVIC Health)', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY-21-01392'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microcurrent TENS device', 'description': 'A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region', 'interventionNames': ['Device: Microcurrent TENS device']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham device', 'description': 'The sham device appears identical to the active device while emitting no therapeutic microcurrent.', 'interventionNames': ['Device: Sham Device']}], 'interventions': [{'name': 'Microcurrent TENS device', 'type': 'DEVICE', 'otherNames': ['Microcurrent neuromodulation device'], 'description': 'The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.', 'armGroupLabels': ['Microcurrent TENS device']}, {'name': 'Sham Device', 'type': 'DEVICE', 'description': 'The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.', 'armGroupLabels': ['Sham device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10028', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Faculty Practice Associates - Mount Sinai Doctors', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Alfred-Marc Iloreta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No additional clinically relevant information will be collected from subjects in the course of the study beyond what is routinely collected and communicated to patients in their standard course of care. Study subjects will not be notified of results until the final analysis of study data is complete. The study results will be submitted for publication and/or presentation at national conferences/journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tivic Health Systems', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alfred-Marc Iloreta', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}