Clinical trial NCT05221333: Sorrel 25R Injector - Sorrel Clinical Study Protocol
Official title: Assessment of Safety and Performance of an Investigational Wearable Injector in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injection Site
Injection Site Reaction
Injection Site Irritation
Keywords: wearable injector
Lead sponsor: Eitan Medical
Sponsor class: INDUSTRY
Collaborators: name: Thomas Jefferson University
First posted: 2022-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a single group of health participants
Primary purpose: BASIC_SCIENCE

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.

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 # 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.

Primary outcomes:
measure: Reliability of SWI
timeFrame: 24 hours
Secondary outcomes:
measure: Incidences of Treatment Emergent Adverse Events of SWI
timeFrame: 1 month
measure: Pain associated with use of SWI
timeFrame: 1 month
Other outcomes:
measure: Overall experience of SWI
timeFrame: 24 hours
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Marc C Torjman
role: PRINCIPAL_INVESTIGATOR
References: