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

Study Title: 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

Type of Study: Post-approval Investigator-Initiated

Trial Design:  Single Centre, Investigator-Initiated, Interventional, Open-Label Comparative Randomised Controlled Clinical Trial

Trial Participants: Healthcare care professionals (HCPs) and adult patients >18 years of age

Planned Sample Size: 80 HCPs and 430 Patient subjects

Follow-up duration: 24 hours

Planned Trial Period: October 15, 2024, to February 15, 2025

Primary Objective: To assess the healthcare professional (HCP)-reported ease of use when administering injections using Aspiel Syringe and Hypodermic Syringe with Needle and to evaluate the levels of pain reported by patients while receiving injections delivered with these devices.

Secondary Objective:  To record the presence or absence of blood aspirate while using an Aspiel Syringe and a Hypodermic Syringe with Needle for injection.

Primary Endpoints:

1.      Ease of Injecting: The ease of injecting medication will be recorded based on the self-reported effort needed by HCPs to push the plunger and expel the syringe contents during the injection process. HCPs will rate the ease of injecting on a scale of 1 to 3 as follows:

Scale 1: Effortless pushing of the plunger and expelling of syringe contents

Scale 2: Moderate effort required to push the plunger and expel the syringe contents

Scale 3: Significant effort is required to push the plunger and expel the syringe contents, possibly with difficulty pushing the plunger using one thumb.

2.      Ease of Aspirating: The ease of aspirating will be recorded based on the self-reported effort experienced by HCPs to retract the syringe plunger for 5 seconds after inserting the needle into the injection site to check for the presence of blood before injecting medication. HCPs will rate the ease of aspirating on a scale of 1 to 3 as follows:

Scale 1: Effortless pulling of the plunger for aspirating after inserting the needle into the injection site.

Scale 2: Moderate effort required while pulling the plunger for aspirating after inserting the needle into the injection site.

Scale 3: Significant effort required to pull the plunger while aspirating after inserting the needle into the injection site, possibly with difficulty pulling using one hand.

3.      Extent of Pain During Injection:  The extent of pain experienced during an injection will be measured and recorded as the pain levels using the Present Pain Index (PPI). Patients will be asked to rate the pain on a scale of 0 to 5 as follows:

Scale 0: No pain

Scale 1: Slight pain

Scale 2: Moderate pain

Scale 3: Intense Pain

Scale 4: Severe pain

Scale 5: Excruciating pain

Secondary Endpoint

1.      Positive or negative aspirate before injecting*: Positive or negative aspirate would be recorded based on the presence or absence of blood aspirate in the syringe, respectively, during or after aspiration for each injection.

*Note: If a positive aspirate is observed, the syringe needle device, along with the drug, should be discarded, and the procedure should be repeated using a similar type of syringe needle device.

Device Name: Aspiel Syringe Needle device with Separate Aspiration Channel (Registered Brand name and Device with CDSCO, India)

Manufacturer Name:  Aspiel Syringes Private Limited

Principle intended use: Parenteral drug delivery (except intravenous)

**Length of time use the device has been in use:**The predicate device has been used for many decades.