Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U44NS109952 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
enrollment, administrative/finance
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
Not provided
Not provided
This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s) and up to 40 non-evaluable subjects for the training phase.
The purpose of this study is to collect robust data from NovaGuide 2 Intelligent Ultrasound System to validate the Velocity Curvature Index (VCI) as a diagnostic biomarker tool to drive clinical decision making for assessing cerebral vascular occlusions confirmed by standard of care Computed Tomography Angiography (CTA) imaging.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort X | Phase 0 will include up to 20 subjects in Cohort X (TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. |
| |
| Cohort Y | Phase 0 will include up to 20 subjects in Cohort Y (No TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. | ||
| Cohort A | Both Phase 1 and Phase 2 of the study will enroll Cohort A (LVO TCD). Cohort A will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
| |
| Cohort B | Both Phase 1 and Phase 2 of the study will enroll Cohort B (Non-LVO TCD). Cohort B will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
| |
| Cohort C | Both Phase 1 and Phase 2 of the study will enroll Cohort C (LVO No-TCD). Cohort C will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 | ||
| Cohort D |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NovaGuide 2 Intelligent Ultrasound System | Device | The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI When Compared Against Standard of Care Imaging. | The primary endpoint for both Phase 1 and Phase 2 of the study is to measure the AUC, Sensitivity, and Specificity of Velocity Curvature Index (VCI) when compared against standard of care CTA imaging for large vessel occlusion assessment. Initial assessment of outcome will be done after 18 months of study start and complete assessment will be done at the end of study's Phase 2. | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects will be enrolled from Stroke centers in the U.S.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Hamilton, Ph.D. | NovaSignal Corp. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI Memorial Hospital | Chattanooga | Tennessee | 37404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27272487 | Background | Hastrup S, Damgaard D, Johnsen SP, Andersen G. Prehospital Acute Stroke Severity Scale to Predict Large Artery Occlusion: Design and Comparison With Other Scales. Stroke. 2016 Jul;47(7):1772-6. doi: 10.1161/STROKEAHA.115.012482. Epub 2016 Jun 7. | |
| 29367333 | Background | Smith EE, Kent DM, Bulsara KR, Leung LY, Lichtman JH, Reeves MJ, Towfighi A, Whiteley WN, Zahuranec DB; American Heart Association Stroke Council. Accuracy of Prediction Instruments for Diagnosing Large Vessel Occlusion in Individuals With Suspected Stroke: A Systematic Review for the 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke. Stroke. 2018 Mar;49(3):e111-e122. doi: 10.1161/STR.0000000000000160. Epub 2018 Jan 24. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort X | Phase 0 will include up to 20 subjects in Cohort X (TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| FG001 | Cohort Y | Phase 0 will include up to 20 subjects in Cohort Y (No TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. |
| FG002 | Cohort A | Both Phase 1 and Phase 2 of the study will enroll Cohort A (LVO TCD). Cohort A will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| FG003 | Cohort B | Both Phase 1 and Phase 2 of the study will enroll Cohort B (Non-LVO TCD). Cohort B will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| FG004 | Cohort C | Both Phase 1 and Phase 2 of the study will enroll Cohort C (LVO No-TCD). Cohort C will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
| FG005 | Cohort D | Both Phase 1 and Phase 2 of the study will enroll Cohort D (Non-LVO No-TCD). Cohort D will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number of participants analyzed for Cohorts A-D is zero because no subjects were enrolled in Cohorts A-D because study was suspended due to lack of funding.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort X | Phase 0 will include up to 20 subjects in Cohort X (TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Endpoint: Area Under the Curve (AUC), Sensitivity, and Specificity of VCI When Compared Against Standard of Care Imaging. | The primary endpoint for both Phase 1 and Phase 2 of the study is to measure the AUC, Sensitivity, and Specificity of Velocity Curvature Index (VCI) when compared against standard of care CTA imaging for large vessel occlusion assessment. Initial assessment of outcome will be done after 18 months of study start and complete assessment will be done at the end of study's Phase 2. | It was pre-specified in "Outcome Measure Description" to report primary endpoint data for Phases 1 and 2 only, which includes subject Cohorts A-D. Phases 1 and 2 were never started due to lack of funding and no data was collected for subjects in Cohorts A-D that would allow data analysis regarding primary and secondary outcome measures. | Posted | 1 day |
|
1 day
Device and procedure related adverse events collected only
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort X | Phase 0 will include up to 20 subjects in Cohort X (TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manja Lenkin | NovaSignal | 8776387251 | manja.lenkin@novasignal.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2020 | Feb 6, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Both Phase 1 and Phase 2 of the study will enroll Cohort D (Non-LVO No-TCD). Cohort D will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
|
| 30293170 | Background | Thorpe SG, Thibeault CM, Wilk SJ, O'Brien M, Canac N, Ranjbaran M, Devlin C, Devlin T, Hamilton RB. Velocity Curvature Index: a Novel Diagnostic Biomarker for Large Vessel Occlusion. Transl Stroke Res. 2019 Oct;10(5):475-484. doi: 10.1007/s12975-018-0667-2. Epub 2018 Oct 6. |
| 30386287 | Background | Thorpe SG, Thibeault CM, Canac N, Wilk SJ, Devlin T, Hamilton RB. Decision Criteria for Large Vessel Occlusion Using Transcranial Doppler Waveform Morphology. Front Neurol. 2018 Oct 17;9:847. doi: 10.3389/fneur.2018.00847. eCollection 2018. |
| 31217091 | Background | Jalaleddini K, Canac N, Thorpe SG, O'Brien MJ, Ranjbaran M, Delay B, Dorn AY, Scalzo F, Thibeault CM, Wilk SJ, Hamilton RB. Objective Assessment of Beat Quality in Transcranial Doppler Measurement of Blood Flow Velocity in Cerebral Arteries. IEEE Trans Biomed Eng. 2020 Mar;67(3):883-892. doi: 10.1109/TBME.2019.2923146. Epub 2019 Jun 17. |
| BG001 | Cohort Y | Phase 0 will include up to 20 subjects in Cohort Y (No TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. |
| BG002 | Cohort A | Both Phase 1 and Phase 2 of the study will enroll Cohort A (LVO TCD). Cohort A will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| BG003 | Cohort B | Both Phase 1 and Phase 2 of the study will enroll Cohort B (Non-LVO TCD). Cohort B will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| BG004 | Cohort C | Both Phase 1 and Phase 2 of the study will enroll Cohort C (LVO No-TCD). Cohort C will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
| BG005 | Cohort D | Both Phase 1 and Phase 2 of the study will enroll Cohort D (Non-LVO No-TCD). Cohort D will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Cohort Y | Phase 0 will include up to 20 subjects in Cohort Y (No TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. |
| OG002 | Cohort A | Both Phase 1 and Phase 2 of the study will enroll Cohort A (LVO TCD). Cohort A will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| OG003 | Cohort B | Both Phase 1 and Phase 2 of the study will enroll Cohort B (Non-LVO TCD). Cohort B will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. |
| OG004 | Cohort C | Both Phase 1 and Phase 2 of the study will enroll Cohort C (LVO No-TCD). Cohort C will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
| OG005 | Cohort D | Both Phase 1 and Phase 2 of the study will enroll Cohort D (Non-LVO No-TCD). Cohort D will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 |
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Cohort Y | Phase 0 will include up to 20 subjects in Cohort Y (No TCD). This phase is for training and feasibility purposes only and data collected will not be used in the final analysis. | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Cohort A | Both Phase 1 and Phase 2 of the study will enroll Cohort A (LVO TCD). Cohort A will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Cohort B | Both Phase 1 and Phase 2 of the study will enroll Cohort B (Non-LVO TCD). Cohort B will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 NovaGuide 2 Intelligent Ultrasound System: The NovaGuide 2 Intelligent Ultrasound system is an adjunctive mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) diagnostic ultrasound system. The system contains a transcranial doppler ultrasound equipment combined with robotic mechanisms used to position ultrasound probes, which assist the user in the acquisition of cerebral blood flow velocity (CBFV) data via a patient's temporal acoustic windows. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | Cohort C | Both Phase 1 and Phase 2 of the study will enroll Cohort C (LVO No-TCD). Cohort C will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | Cohort D | Both Phase 1 and Phase 2 of the study will enroll Cohort D (Non-LVO No-TCD). Cohort D will enroll 54 subjects in Phase 1 and 156 subjects in Phase 2 | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |