Trial Outcomes & Findings for Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas (NCT NCT03353246)
NCT ID: NCT03353246
Last Updated: 2019-08-20
Results Overview
Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
Up to 30 days after first CT scan
Results posted on
2019-08-20
Participant Flow
Participant milestones
| Measure |
InfraScanner 2000™
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Overall Study
STARTED
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500
|
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Overall Study
COMPLETED
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500
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of InfraScanner 2000™ in Detecting Subdural and Epidural Hematomas
Baseline characteristics by cohort
| Measure |
InfraScanner 2000™
n=500 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Age, Continuous
|
55.4 years
STANDARD_DEVIATION 25.4 • n=5 Participants
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Sex: Female, Male
Female
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211 Participants
n=5 Participants
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Sex: Female, Male
Male
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289 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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104 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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396 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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28 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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10 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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168 Participants
n=5 Participants
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Race (NIH/OMB)
White
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231 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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63 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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500 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: For participants who had more than one scan, the first scan was used.
Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=500 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level
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85.6 percentage
Interval 78.8 to 92.3
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PRIMARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=500 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level
|
88.5 percentage
Interval 83.8 to 93.1
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PRIMARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: For participants who had more than one scan, the first scan was used.
Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=500 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
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95.7 percentage
Interval 93.7 to 97.7
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PRIMARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=581 Scans
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
|
95.5 percentage
Interval 93.5 to 97.5
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PRIMARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: For participants who had more than one scan, the first scan was used.
Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=500 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
|
16.0 percentage
Interval 9.1 to 23.0
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PRIMARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=581 Scans
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
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10.1 percentage
Interval 5.7 to 14.5
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PRIMARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: For participants who had more than one scan, the first scan was used.
Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=500 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level
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3.8 percentage
Interval 1.9 to 5.7
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PRIMARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.
Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=581 Scans
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level
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5.2 percentage
Interval 3.1 to 7.4
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SECONDARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.
Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=482 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level
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94.2 percentage
Interval 89.2 to 99.1
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SECONDARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.
Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=482 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level
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95.7 percentage
Interval 93.7 to 97.7
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SECONDARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=98 Hematomas
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
epidural hematoma (EDH)
|
100.0 percentage
Interval 54.1 to 100.0
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Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
subdural hematoma (SDH)
|
96.9 percentage
Interval 92.6 to 100.0
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Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
subarachnoid (SAH)
|
75.0 percentage
Interval 50.5 to 99.5
|
|
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
intracerebral (IH)
|
100.0 percentage
Interval 79.4 to 100.0
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SECONDARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=482 Participants
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
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|---|---|
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False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
epidural hematoma (EDH)
|
0.0 percentage
Interval 0.0 to 0.97
|
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False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
subdural hematoma (SDH)
|
0.5 percentage
Interval 0.0 to 1.3
|
|
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
subarachnoid (SAH)
|
0.8 percentage
Interval 0.0 to 1.7
|
|
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level
intracerebral (IH)
|
0.0 percentage
Interval 0.0 to 0.97
|
SECONDARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=180 CT scans
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
|
|---|---|
|
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
epidural hematoma (EDH)
|
90.9 percentage
Interval 73.9 to 100.0
|
|
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
subdural hematoma (SDH)
|
98.3 percentage
Interval 96.0 to 100.0
|
|
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
subarachnoid (SAH)
|
88.0 percentage
Interval 75.3 to 100.0
|
|
Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
intracerebral (IH)
|
96.2 percentage
Interval 88.8 to 100.0
|
SECONDARY outcome
Timeframe: Up to 30 days after first CT scanPopulation: Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.
Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.
Outcome measures
| Measure |
InfraScanner 2000™
n=180 CT scans
All patients entered onto the trial will undergo at least one cranial scanning using the InfraScanner 2000™ within 30 minutes of CT. Patients will be scanned using the InfraScanner 2000™ within 30 minutes of each subsequent CT. Patients will know the results of the CT but not the InfraScanner 2000™. The standard for comparison will be determined as follows. A CT result that is positive for hematoma will be considered a true positive and a CT result that is negative for hematoma will be considered a true negative. In cases where the results of the CT are negative for hematoma and the results of the InfraScanner 2000™ are positive consideration of further follow-up will be given on a case-by-case basis.
InfraScanner 2000™: The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
|
|---|---|
|
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
epidural hematoma (EDH)
|
0.3 percentage
Interval 0.0 to 0.8
|
|
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
subdural hematoma (SDH)
|
0.5 percentage
Interval 0.0 to 1.3
|
|
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
subarachnoid (SAH)
|
0.8 percentage
Interval 0.0 to 1.7
|
|
False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level
intracerebral (IH)
|
0.3 percentage
Interval 0.0 to 0.8
|
Adverse Events
InfraScanner 2000™
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Haglund, M.D., Ph.D.
Duke University Medical Center
Phone: 919-684-6936
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place