Assessment of Safety and Performance of an Investigational Wearable Injector in Healthy Volunteers

Eitan Medical1 site in 1 country20 target enrollmentAugust 23, 2021

ConditionsInjection Site Injection Site Reaction Injection Site Irritation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Injection Site
Sponsor: Eitan Medical
Enrollment: 20
Locations: 1
Primary Endpoint: Reliability of SWI
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.

Detailed Description

A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers. The study will enroll up to 25 healthy adult subjects. Each subject will perform a maximum of 5 visits during the study over a period of approximately 2 months; a virtual visit for informed consent, two in-person visits for device evaluation, and two follow-up virtual visits to evaluate the skin and surrounding tissue for adverse events.

Registry

clinicaltrials.gov

Start Date

August 23, 2021

End Date

December 30, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eitan Medical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to ≤ 40 years.
•Subject understands the English language, understands the risks, benefits, and alternatives to this research study, and is willing and able to give written informed consent.
•Subject has no active signs/symptoms of a viral infection for 10 days prior to visit #
•Body Mass Index between 20 to 35 kg/m2 (inclusive).
•Subject willing and able to comply with study procedures.
•American Society of Anaesthesiology Physical status (ASA PS) classification 1

Exclusion Criteria

•Current use of aspirin at a daily dose \> 81 mg,
•Current use of any medication that may adversely affect blood coagulation (i.e. warfarin, Xarelto, Eliquis etc.)
•Presence of any tattoos, discoloration, acne, scars, bruises, cuts, abrasions, rashes, hernias, or inflammation within the skin or subcutaneous tissue of the abdomen that could interfere with the infusion of saline or observation of study results, at the discretion of the investigator..
•History of significant skin allergy, irritation, or hypersensitivity to medical adhesives or adhesive tape.
•History of significant allergic reaction to medical saline solution.
•History of significant allergic reaction to the skin antiseptic solutions alcohol or chlorhexidine.
•History of any neurologic disease that may affect the perception of pain/discomfort (stroke, peripheral neuropathy).
•Current use of any medication that may affect the perception of pain/discomfort (opioids, NSAIDs, topical local anesthetics) at the discretion of the investigator.
•Current use of any medical condition or medication that to the opinion of the investigator may affect the risk for a serious adverse event
•Female of childbearing age with a positive pregnant test, or currently breast feeding.