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Comparing the Real-World Benefits of Aspiel Syringe vs. Regular Syringe with Needle: A Clinical Study

Clinical Evaluation of Benefits of Aspiel Syringe over Hypodermic Syringe with Needle in Real-world Settings: An Open-Label Single-Centre Comparative Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074881
Enrollment
430
Registered
2024-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Syringe Needle device with Separate Aspiration Channel: The participants requiring injections (other than intravascular) for drugs or vaccines, nerve blocks, plexus blocks, infiltration

Sponsors

B J Medical College and Civil Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient participants: 1. Patients who are non-critical and need to receive injections (other than intravenous) for drugs/vaccines, nerve blocks, plexus blocks, infiltration anaesthesia, or depot injections. 2. The individuals capable and willing to provide informed consent for participation in the clinical trial HCP participants: Licensed Healthcare care professionals (HCPs: registered nurses, certified nursing assistants, and registered medical practitioners) with at least six months of experience administering injections are eligible to participate in the study as intended users of Aspiel® Syringe and Hypodermic Syringe with Needle.

Exclusion criteria

Exclusion criteria: Patient Participants: 1. Patients who are allergic to the intended injection drug 2. Patients who require administration of opaque drugs 3. Patients who have a mental illness 4. Patients who are unable to comprehend the protocol or provide informed consent 5. Patients already taking pain medications. HCP participants: HCPs with any previous contact with the Aspiel® Syringe will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Ease of injection and ease of aspiration as reported by healthcare professionals and extent of pain as reported by patientsTimepoint: During each injection

Secondary

MeasureTime frame
Positive or negative aspirate before injectingTimepoint: During each injection procedure

Countries

India

Contacts

Public ContactDr Prujal Parekh

Sal Institute of Medical Sciences, Ahmedabad

prujalparekh@gmail.com919099079269

Outcome results

None listed

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