Sorrel 25R Injector - Sorrel Clinical Study Protocol

Last updated: January 20, 2022
Sponsor: Eitan Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05221333
VAL-15144-0005662
  • Ages 18-40
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Age 18 to ≤ 40 years. Subject understands the English language, understands the risks, benefits, and alternativesto 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

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 couldinterfere with the infusion of saline or observation of study results, at the discretion ofthe investigator.. History of significant skin allergy, irritation, or hypersensitivity to medical adhesivesor adhesive tape. History of significant allergic reaction to medical saline solution. History of significant allergic reaction to the skin antiseptic solutions alcohol orchlorhexidine. 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 investigatormay 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 deviceplacement Any current or unstable cardiac, pulmonary, hepatic, renal, neurologic, gastrointestinal,endocrine, immune, endocrine, musculoskeletal, coagulation disorder, or infectious diseasewhich in the opinion of the Investigator would place the subject at risk or influence theconduct 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 theirinfusion sites.

Study Design

Total Participants: 20
Study Start date:
August 23, 2021
Estimated Completion Date:
December 30, 2022

Study 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.

Connect with a study center

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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