Clinical Evaluation of Low Cost Single use Safety syringe
Not Applicable
- Conditions
- Health Condition 1: null- Patients who require dose administration by parental route using the syringe or phlebotomy procedure as a part of their treatment or diagnosis.
- Registration Number
- CTRI/2017/06/008864
- Lead Sponsor
- Indian Council of Medical Research ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients who require treatment intervention by either intra muscular or intra venous or sub cutaneous OR
Patients who require phlebotomy procedures for blood withdrawal
Exclusion Criteria
Patients who have difficulties in parental administration
Use of anti coagulants and anti platelet agents
Known existing uncontrolled coagulopathy
History of clotting disorders or thrombocytopaenia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ease of Use <br/ ><br>Ability to activate mechanism single handed <br/ ><br>Time to operate <br/ ><br>Accuracy in delivery of content <br/ ><br>Pain or Trauma experienced by administrator and subject <br/ ><br>Blood splatter <br/ ><br>Triggering of safety mechanism <br/ ><br>Pain or discomfort experienced in any upon Sheath activationTimepoint: Direct Observation after the use of the safety syringe
- Secondary Outcome Measures
Name Time Method Visibility of Calibration <br/ ><br>Effectiveness in delivery <br/ ><br>Safety offered <br/ ><br>Leakage during injection <br/ ><br>Reliability <br/ ><br>Need for additional syringe <br/ ><br>Needle stick incidencesTimepoint: Direct observation immediately after the use of the safety syringe