NCT05221333

Sorrel 25R Injector - Sorrel Clinical Study Protocol

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Eitan Medical · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Injection Site
• Injection Site Reaction
• Injection Site Irritation

Interventions

Type	Name	Description
DEVICE	Sorrel Wearable Injector	Use of Sorrel Wearable Injector in pilot study

Timeline

• Start date: 2021-08-23
• Primary completion: 2022-12-15
• Completion: 2022-12-30
• First posted: 2022-02-03
• Last updated: 2022-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study