Sorrel 25R Injector - Sorrel Clinical Study Protocol

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

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

Study Overview

• Status: Recruiting
• Conditions: Injection Site Irritation; Injection Site Reaction; Injection Site
• Intervention / Treatment: Device: Sorrel Wearable Injector

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc C Torjman, Ph.D.; Phone Number: 215-955-6161; Email: marc.torjman@jefferson.edu
• Study Contact Backup: Name: Jennifer Lessin, RN; Phone Number: 215-955-5804; Email: Jennifer.Lessin@Jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Marc C Torjman, Ph.D; Phone Number: 215-955-6161; Email: marc.torjman@jefferson.edu
      • Contact: Jennifer Lessin, RN; Phone Number: 2159555804; Email: jennifer.lessin@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 # 2.

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.

Study subject refuses to allow clipping of excess abdominal hair at the site of device placement

Any current or unstable cardiac, pulmonary, hepatic, renal, neurologic, gastrointestinal, endocrine, immune, endocrine, musculoskeletal, coagulation disorder, or infectious disease which in the opinion of the Investigator would place the subject at risk or influence the conduct of the study, or interpretation of the results.

Current participation in another clinical drug or device study.

Inability of the subject to comply with all study procedures.

Inability of the subject to understand the information required for monitoring their infusion sites.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy participants; Up to 25ml of saline administered through OBI	Device: Sorrel Wearable Injector; Use of Sorrel Wearable Injector in pilot study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of SWI	70% successful injection confirmed by visual inspection of investigator	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidences of Treatment Emergent Adverse Events of SWI	Evaluation of AEs	1 month
Pain associated with use of SWI	Pain assessment based on visual analog scale (VAS), higher score means worse outcome	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall experience of SWI	Assessment of overall experience based on patient questionnaire	24 hours

Collaborators and Investigators

• Sponsor: Eitan Medical
• Collaborators: Thomas Jefferson University
• Investigators: Principal Investigator: Marc C Torjman, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: wearable injector
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Drug-Related Side Effects and Adverse Reactions; Extravasation of Diagnostic and Therapeutic Materials; Injection Site Reaction
• Other Study ID Numbers: VAL-15144-0005662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study for internal use only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No