A Pilot Open-Label Randomized Study to Evaluate the Safety, Tolerability, and Acceptability of the IntegriMedical® Needle Free Injection System versus a Conventional Needle-Based System in Healthy Volunteers, Using Normal Saline as a Placebo.

Journal: Medical devices (Auckland, N.Z.)
Published Date: Dec 27, 2024

Abstract

PURPOSE: The study aimed to assess the safety, tolerability, and acceptability of the IntegriMedical® Needle Free Injection System (IM-NFIS) compared to conventional hypodermic needle injections (CHN) in healthy adult subjects across multiple injection sites.

Authors

  • Almas Pathan
    Jehangir Clinical Development Centre, Pune, Maharashtra, India.
  • Kavitha Shetty Narasimha
    IntegriMedical Private Limited, Pune, Maharashtra, India.
  • Ankur Naik
    IntegriMedical Private Limited, Pune, Maharashtra, India.
  • Arati Ranade
    Jehangir Clinical Development Centre, Pune, Maharashtra, India.

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