Injection SiteNCT05221333
Sorrel 25R Injector - Sorrel Clinical Study Protocol
A study testing Sorrel Wearable Injector in people with Injection Site and Injection Site Reaction, run by Eitan Medical at 1 site in United States.
Trial summary
A prospective, open-label, single-center pilot study to evaluate the performance, safety and usability of the investigational SWI Device in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Injection Site, Injection Site Reaction, Injection Site Irritation
- What is being tested?
- Sorrel Wearable Injector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Marc C Torjman, Ph.D, 215-955-6161, marc.torjman@jefferson.edu
Jennifer Lessin, RN, 2159555804, jennifer.lessin@jefferson.edu
About this study
Official title: Assessment of Safety and Performance of an Investigational Wearable Injector 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.
Read the 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.
- Being tested
- Sorrel Wearable Injector
- Keywords
- wearable injector
- Medical subject headings
- Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorrel Wearable InjectorDevice
Use of Sorrel Wearable Injector in pilot study
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Other | Up to 25ml of saline administered through OBI Receives: Device: Sorrel Wearable Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of SWI
70% successful injection confirmed by visual inspection of investigator
Measured: 24 hours
Secondary outcomes (2)
Incidences of Treatment Emergent Adverse Events of SWI
Evaluation of AEs
Measured: 1 month
Pain associated with use of SWI
Pain assessment based on visual analog scale (VAS), higher score means worse outcome
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start23 Aug 2021
- Primary completion15 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injection SiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a single group of health participants
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eitan Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Marc C Torjman, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221333
- Sponsor's protocol ID
- VAL-15144-0005662
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a pilot study for internal use only
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Performance of an Investigational Wearable Injector in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05221333
- Acronym / sponsor ID
- VAL-15144-0005662
- Keywords
- wearable injector
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Eitan MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single group of health participants
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | Other | Device: Sorrel Wearable InjectorUp to 25ml of saline administered through OBI |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorrel Wearable InjectorUse of Sorrel Wearable Injector in pilot study | Device | Healthy participants |
Primary outcome
Reliability of SWI
Time frame: 24 hours
70% successful injection confirmed by visual inspection of investigator
2 secondary outcomes
Incidences of Treatment Emergent Adverse Events of SWI
Time frame: 1 month
Pain associated with use of SWI
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: No. This is a pilot study for internal use only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc C Torjman principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorrel Wearable Injector in people with Injection Site and Injection Site Reaction, run by Eitan Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc C Torjman, Ph.D. (215-955-6161, marc.torjman@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of SWI (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.