Sorrel 25R Injector - Sorrel Clinical Study Protocol

Injection Site Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05221333
• Other study ID #: VAL-15144-0005662
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2021
• Source: Eitan Medical
• Contact: Marc C Torjman, Ph.D.
• Phone: 215-955-6161
• Email: marc.torjman[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Injection Site
• Injection Site Irritation
• Injection Site Reaction

Intervention

Device:
• Sorrel Wearable Injector
Use of Sorrel Wearable Injector in pilot study

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Eitan Medical	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall experience of SWI	Assessment of overall experience based on patient questionnaire	24 hours
Primary	Reliability of SWI	70% successful injection confirmed by visual inspection of investigator	24 hours
Secondary	Incidences of Treatment Emergent Adverse Events of SWI	Evaluation of AEs	1 month
Secondary	Pain associated with use of SWI	Pain assessment based on visual analog scale (VAS), higher score means worse outcome	1 month