[IMG]Search[IMG] ↓ Full text Evaluation of an investigational...

Search
↓ Full text
Evaluation of an investigational wearable injector in healthy human volunteers.
Torjman MC, et al. Expert Opin Drug Deliv. 2016.
Show full citation
Abstract
OBJECTIVES: Introduction of a wearable device for subcutaneous delivery of larger volume bolus injections would encourage patient compliance and reduce the burden on healthcare services. With one such wearable device commercially available, this study examined the safety and functionality of an investigational device in volunteers.

METHODS: Four devices were applied to the subject's abdomen: 1) Investigational Device, 2) Investigational Device: subject movement, 3) Control Device: FDA-cleared syringe driver with FDA-cleared infusion set, 4) Control Device: FDA-cleared syringe driver attached to investigational device. Three milliliters of saline were infused through the four devices over 3 minutes.

RESULTS: 84 devices were applied to 21 subjects. Three milliliters of saline were safely delivered subcutaneously from the investigational and control devices. Two control devices had occlusions and in each case the pump reached its high pressure limit of 12 psi. VAS pain measurements showed minimal pain for all subjects. Pain scores were significantly (p < 0.001) higher than baseline at the end of injection: mean pain level ranged from 2.0-22.0 mm.

CONCLUSIONS: The investigational device performed as intended with minimal pain during needle insertion and infusion, and no leaking of fluid at the skin puncture site. Two occlusions occurred with the control devices.

PMID
27809609 [PubMed - as supplied by publisher]
Full text
Full text at journal site
Similar articles

• Clinical immunogenicity of measles, mumps and rubella vaccine delivered by the Injex jet injector: comparison with standard syringe injection.
  Randomized controlled trial
  Sarno MJ, et al. Pediatr Infect Dis J. 2000.
• Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers.Berteau C, et al. Patient Prefer Adherence. 2010.
• Comparison of pharmacokinetics and safety of pegfilgrastim administered by two delivery methods: on-body injector and manual injection with a prefilled syringe.
  Randomized controlled trial
  Yang BB, et al. Cancer Chemother Pharmacol. 2015.
• Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering.
  Review article
  Edwards ES, et al. Expert Opin Drug Deliv. 2015.
• Jet injection devices for the needle-free administration of compounds, vaccines, and other agents.
  Review article
  Logomasini MA, et al. Int J Pharm Compd. 2013.

See all
Full website

• NIH
  
• NLM
  
• NCBI
  
• Help