| CTRI Number |
CTRI/2021/11/038191 [Registered on: 23/11/2021] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
To determine if the Sense device can detect if bleeding in the brain is getting bigger. |
Scientific Title of Study
Modification(s)
|
A Prospective, Two-Stage, Non-randomized, Multi-center Within Patient Comparison Study to
Evaluate the SENSE Device’s Ability to Detect Intracranial Hemorrhage |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NCT04642443 |
ClinicalTrials.gov |
| SENSE-003 V5.1 dated 25 May 2023 |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Umesh Pawa |
| Designation |
Director |
| Affiliation |
DUV Healthcare Pvt. Ltd. |
| Address |
Plot No.372, Udyog Vihar Phase- II, Gurugram- 122016
Gurgaon
HARYANA
122016
India |
| Phone |
9810163940 |
| Fax |
|
| Email |
Umesh.Pawa@labindia.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Umesh Pawa |
| Designation |
Director |
| Affiliation |
DUV Healthcare Pvt. Ltd. |
| Address |
Plot no.372, Udyog Vihar Phase- II, Gurugram- 122016
Gurgaon
HARYANA
122016
India |
| Phone |
9810163940 |
| Fax |
|
| Email |
Umesh.Pawa@labindia.com |
|
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Source of Monetary or Material Support
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| Sense Diagnostics, Inc. 1776 Mentor Ave, Suite 426, Cincinnati, Ohio, United States of America |
|
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Primary Sponsor
|
| Name |
Sense Diagnostics Inc |
| Address |
1776 Mentor Ave, Suite 426, Cincinnati, Ohio, United States of America |
| Type of Sponsor |
Other [Medical Device Company] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| PAT Pharma Consultants India Private Ltd |
205, IInd Floor, Vikas Surya Arcade,CU Block Market, Pitampura, North West Delhi Delhi -110034, Delhi, India |
|
Countries of Recruitment
Modification(s)
|
India
United States of America
Canada |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Bhatia |
All India Institute of Medical Science |
Department of Neurology, 6th floor, Sri Aurobindo Marg, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
911126546625
911126588663
rohitbhatia71@yahoo.com |
| Dr Vivek Nambiar |
Amrita Institute of Medical Science and Research Center |
Department of Neurology, Stroke Medicine, B Block, 1st Floor, Ponekkara, Edapally, Kochi, Kerala - 682041
Ernakulam
KERALA |
919400315050
dr.vivek.in@gmail.com |
| Dr Shalini Nair |
Christian Medical College |
Department of Neurological Science, 3rd floor, Neurology, Neuro Research Room, Neuro Office, Ida Scudder Road, Vellore, Tamilnadu - 632002
Vellore
TAMIL NADU |
918489078762
drshalininair@cmcvellore.ac.in |
| Dr Prakash Mahantshetti |
KLES Dr. Prabhakar KORE Hospital and Medical Research Center |
Consultation Room No 1, OPD No 31, Department of Neurosurgery , Nehru Nagar, Belagavi Belgaum, Karnataka-590010
Belgaum
KARNATAKA |
919880063259
drprakashsm@gmail.com |
| Dr Komal Prasad Chandrachari |
Mazumdar Shaw Medical Centre - Unit of Narayana Hrudayalaya Limited |
Department of Neurology, Narayana Health City, 258A,Bommasandra Industrial Area, Anekal Taluk, Bangalore-560099
Bangalore
KARNATAKA |
919880305155
drkomalprasad@gmail.com |
| Dr Anshul Gupta |
Sir ganga Ram Hospital |
Department of Neurosurgery, Room no 1412, 4th Floor, Old Building, SGRH Marg, Rajninder Nagar, New Delhi-110060
New Delhi
DELHI |
919999336476
anshul.sgrh@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee of Amrita Institute of Medical Sciences |
Approved |
| Institutional ethics committee of KLE academy of higher education and research |
Approved |
| Institutional Review board, Christian Medical College |
Approved |
| Narayana Health Academic Ethics Committee |
Approved |
| Sir Ganga Ram Hospital Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I678||Other specified cerebrovascular diseases, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active Comparator Intracranial Hemorrhage |
The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patients brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of three parts:
1. A molded plastic headpiece containing the antenna array
2. An intermediate control unit that contains:
a. The driving electronics for the array of antennae
3. A processing control unit that contains:
a. A spectrum analyzer
b. The operating software that controls the device function and data acquisition, processing and archiving.
c. The user interface for inputting patient information and displaying the output of the data
|
| Comparator Agent |
Active Comparator Traumatic Brain Injury |
The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patients brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of three parts:
1. A molded plastic headpiece containing the antenna array
2. An intermediate control unit that contains:
a. The driving electronics for the array of antennae
3. A processing control unit that contains:
a. A spectrum analyzer
b. The operating software that controls the device function and data acquisition, processing and archiving.
c. The user interface for inputting patient information and displaying the output of the data
|
| Intervention |
SENSE Device |
The SENSE Device is indicated for the monitoring of intracranial hemorrhage by detecting a suspected increase in blood volume within the cranial vault. It is an adjunctive device to the clinical evaluation in the acute hospital setting of patients 22 years of age or older with suspected or known intracranial hemorrhage. The device is indicated for use to monitor patients for intracranial hemorrhage expansion between CT scans but should not serve as a substitute for these scans. |
|
Inclusion Criteria
Modification(s)
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| Age From |
22.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who meet all of the following inclusion criteria will be considered candidates for study enrollment:1. Male or female patients age 22 years and older 2. CT obtained in the mobile stroke unit, emergency department (ED) or hospital
Informed consent provided by study subject or, if subject is unable, by subject’s next of kin or legal guardian. |
|
| ExclusionCriteria |
| Details |
All subjects meeting any of the following criteria will be excluded from this study:
1. Female patients who are pregnant or lactating
2. SENSE device cannot be applied within 6 hours of a standard of care CT,
3. Metallic intracranial clip, coil, device (such as ICP monitor),or penetrating metallic shrapnel,
4. Metallic EEG leads in place at the time of planned enrollment,
5. Open skull fracture (closed skull fracture is not an exclusion),
6. Placement of an intraventricular catheter prior to enrollment,
7. Hemorrhagic transformation of ischemic stroke,) as etiology of ICH,
8. Treatment with intravenous thrombolysis or
embolectomy prior to enrollment,
9. Clinical uncertainty about whether intracranial
hemorrhage is present on the pre-enrollment head
CT, and
10. Presence or history of any other condition or finding that, in the investigator’s opinion, makes the patient unsuitable as a candidate for SENSE device monitoring or study participation or may confound the outcome of the study.
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
Detection of ICH is the primary endpoint for this study. To establish the sensitivity (primary) and specificity (key
secondary) for ICH detection. The results from the CT (ICH
versus no ICH) scan will serve as the gold standard |
Time Frame: 48 hours |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To estimate the specificity of the SENSE device for classifying patients undergoing head CT as non-ICH versus ICH. |
The study duration is a total of up to 24 hours which includes at least 5 minutes of
SENSE device monitoring, & a follow-up at 24 hours ± 12 hours. |
To estimate the positive predictive value (PPV) of the SENSE device for classifying
patients undergoing head CT as ICH versus non-ICH. |
The study duration is a total of up to 24 hours which includes at least 5 minutes of
SENSE device monitoring, & a follow-up at 24 hours ± 12 hours. |
To estimate the negative predictive value (NPV) of the SENSE device for classifying
patients undergoing head CT as ICH versus non-ICH.
|
The study duration is a total of up to 24 hours which includes at least 5 minutes of
SENSE device monitoring, & a follow-up at 24 hours ± 12 hours. |
To estimate the PPV, NPV, specificity & sensitivity of the SENSE device for correctly
classifying patients with intracranial hemorrhage after excluding patients whose total
intracranial hemorrhage volume is less than 1 mL. |
The study duration is a total of up to 24 hours which includes at least 5 minutes of
SENSE device monitoring, & a follow-up at 24 hours ± 12 hours. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="320"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
05/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/01/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
No |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a pivotal, prospective, non-randomized, multi-center, comparison of the
SENSE device and CT scans. All subjects who meet eligibility criteria should be
enrolled. The algorithm for ICH detection described above will be tested in an
independent cohort of ~120 subjects each with and without ICH have been enrolled. The
gold standard will be based on the CT results. CT scans will be grouped into: 1) ICH or,
2) non-ICH. ICH is defined as a diagnosis of primary spontaneous ICH (parenchymal intracerebral
hemorrhage, subarachnoid hemorrhage, spontaneous subdural hematoma) or traumatic
intracranial bleeding (defined as subarachnoid hemorrhage, epidural hemorrhage,
subdural hemorrhage and/or traumatic contusions/intraparenchymal hemorrhage). All images will be reviewed by an independent neuroradiology core lab for classification
as ICH or non-ICH, and for ICH volume estimation. The treating clinicians and
independent neuroradiology core lab will be blinded to the SENSE device findings. For
subjects who have multiple CT scans, the CT scan closest in time (while still preceding)
SENSE device placement will be used for adjudication. |