An interventional study of Sorrel Wearable Injector in Injection Site, Injection Site Reaction and Injection Site Irritation, sponsored by Eitan Medical. Status unknown at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-03.
Sponsored by Eitan Medical · Not applicable, Interventional, and Basic science
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers.
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.
22 studies on the registry are indexed under Injection Site Reaction; 3 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 17 interventional studies indexed under Injection Site Reaction.
Browse Injection Site Reaction studies →This is the only study on the registry with Eitan Medical as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Subject has no active signs/symptoms of a viral infection for 10 days prior to visit # 2.
between 20 to 35 kg/m2 (inclusive).
Subject willing and able to comply with study procedures.
American Society of Anaesthesiology Physical status () 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Up to 25ml of saline administered through OBI
Device: Sorrel Wearable Injector
Use of Sorrel Wearable Injector in pilot study
Reliability of SWI
70% successful injection confirmed by visual inspection of investigator
Time frame: 24 hours
Incidences of Treatment Emergent Adverse Events of SWI
Evaluation of AEs
Time frame: 1 month
Pain associated with use of SWI
Pain assessment based on visual analog scale (VAS), higher score means worse outcome
Time frame: 1 month
Overall experience of SWI
Assessment of overall experience based on patient questionnaire
Time frame: 24 hours
Plan to share: No — This is a pilot study for internal use only
No publications or documents are linked to this record.
Started Aug 2021 (actual). Primary completion is estimated for Dec 2022, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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