Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-08-23
2022-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Healthy participants
Up to 25ml of saline administered through OBI
Sorrel Wearable Injector
Use of Sorrel Wearable Injector in pilot study
Interventions
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Sorrel Wearable Injector
Use of Sorrel Wearable Injector in pilot study
Eligibility Criteria
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Inclusion Criteria
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 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Thomas Jefferson University
OTHER
Eitan Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Marc C Torjman
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VAL-15144-0005662
Identifier Type: -
Identifier Source: org_study_id
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