What is the best answer, how quickly do nerves regenerate?
1-2 mm per day
What filament represents normal sensation range for SWMT?
Green (2.83)
What is the Primary Endpoint?
Michigan Hand Questionnaire (MHQ) at Week 24 (2 Domains)
What is Solution #1?
Sterile Calcium-free Hypotonic Saline
What would be considered a significant abnormality found during the screening physical exam?
Numbness on unaffected side
If you receive an email from TPS for historical patient activity, what information will be requested?
CPT Codes
What would be an example of an activity of daily living?
All of the above.
What types of nerve repairs are allowed in NTx24301 study?
Direct Repair
What is the desired interpretation of the information for the BASELINE MHQ?
The subject’s perceived degree of functional ability prior to the injury
What is FALSE about the storage conditions for NTX-001?
Kits with easy access to open by surgical staff
What is the reason for some screen failure data to be recorded?
A and b only.
What support does TPS offer to study sites?
Staffing, Monitoring, and Operational Support
What does MRCC Score M2 represent?
Active movement with gravity eliminated
Which of these is a method of testing sensory function?
Two-Point Discrimination
What is considered the 48 hour window related to inclusion?
Time of transection to first exposure to Solution #1
What is Solution #2?
Polyethylene glycol 3350 at 50% concentration
Which of the following actions must be taken if a subject fails to return to the clinic for a required study visit?
All of the above.
Who will you contact if you need help to urgently add and randomize a subject?
Brian or Benjamin with LBR
Surgeons will measure the distance from the transection (proximal) to the most distal area of innervation in the upper extremity in an effort to?
Determine anticipated time of functional recovery
The SWMT is assessed based on type of nerve injury. What is tested when sensory only nerves are injured?
The ulnar and radial sides on the affected digits are tested (palmar crease to fingertip)
When is the subject randomized?
In the OR after the nerve injury class is met and the nerve is determined to be amenable to direct repair
What is FALSE in the description of Study Drug/Device?
A pouched tray which contains the following sizes; 1mm, 2mm, 3mm, and 6mm
What was the average age and gender demographic in this population for upper extremity nerve injuries in the phase 2 study?
Males, average 40 years of age
What tab do you click to Add a New Subject?
Subject list
Nerve Conduction Velocity (NCV) is done on sensory and mixed motor nerve injuries. If NCV is NOT normal on the affected nerve but is normal on the contralateral at Week 12 what action is taken?
This assessment will need to be reperformed at Week 24
The MRCC Sensory assessment includes static 2 point discrimination measurements, which of these is normal?
1 to 5 mm
Which of these statements are FALSE?
If multiple nerves are transected, a subject cannot be evaluated for enrollment
What activity does Solution #3 perform?
Both a and b
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a unique suicide risk assessment. Which of these answers are TRUE?
If the subject is rated at high risk, the subject is considered a screen fail and study staff needs to refer to appropriate service for care
Who should you contact if your Clinical ink activation code has expired and you cannot complete your training to gain access to the system?
Clinical ink Support at Support@Clinicalink.com or call 1-800-301-5033 (US Toll Free)