Skip to content

Clinical Evaluation of Low Cost Single use Safety syringe

A Multicenter, Open label, prospective study to evaluate safety and effectiveness of the safety syringe developed by Alfa corpuscles Pvt Ltd, India in patients who require dose administration by Parenteral route using the syringe or phlebotomy procedure as a part of their treatment/ diagnosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008864
Enrollment
1000
Registered
2017-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Intervention1: Safety Syringe Developed by Alfa Corpuscles Pvt.Ltd: Low Cost Indigenous single use safety syringe with passive syringe actuated needle stick injury & reuse prevention mechanism Control

Sponsors

Indian Council of Medical Research ICMR
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Ease of Use Ability to activate mechanism single handed Time to operate Accuracy in delivery of content Pain or Trauma experienced by administrator and subject Blood splatter Triggering of safety mechanism Pain or discomfort experienced in any upon Sheath activationTimepoint: Direct Observation after the use of the safety syringe

Secondary

MeasureTime frame
Visibility of Calibration Effectiveness in delivery Safety offered Leakage during injection Reliability Need for additional syringe Needle stick incidencesTimepoint: Direct observation immediately after the use of the safety syringe

Countries

India

Contacts

Public ContactKunal B

Alfa Corpuscles Pvt. Ltd

atul.sardana@alfacorpuscles.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026