Sorrel 25R Injector - Sorrel Clinical Study Protocol

NCT05221333 | Unknown FDA Device

• 1 other identifier: VAL-15144-0005662
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Injection Site; Injection Site Reaction; Injection Site Irritation

Keywords

wearable injector

Outcome Measures

Primary Outcomes (1)

• Reliability of SWI

  70% successful injection confirmed by visual inspection of investigator

  24 hours

Secondary Outcomes (2)

• Incidences of Treatment Emergent Adverse Events of SWI

  1 month

• Pain associated with use of SWI

  1 month

Other Outcomes (1)

• Overall experience of SWI

  24 hours

Study Arms (1)

Healthy participants

OTHER

Up to 25ml of saline administered through OBI

Device: Sorrel Wearable Injector

Interventions

Sorrel Wearable Injector DEVICE

Use of Sorrel Wearable Injector in pilot study

Healthy participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eitan Medical: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Injection Site Reaction

Condition Hierarchy (Ancestors)

Extravasation of Diagnostic and Therapeutic Materials; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Marc C Torjman

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc C Torjman, Ph.D.

CONTACT

215-955-6161; marc.torjman@jefferson.edu

Jennifer Lessin, RN

CONTACT

215-955-5804; jennifer.lessin@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a single group of health participants

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: February 3, 2022
• Study Start: August 23, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 30, 2022
• Last Updated: February 3, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)