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The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.
This study is a monocentric, open-label, cross-over, feasibility and exploratory study with no acceptance criteria. Up to 70 healthy volunteers will be enrolled and followed up for 7 weeks at maximum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "In-Clinic wear first" | Experimental | Participant will wear the devices first during 27 hr in-clinic wear first followed by injection, then a short-term wear period in-clinic followed by injection, and finally at home for 27 hrs followed by injection. |
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| "Home wear first" | Experimental | Participant will wear the devices at home first with return to clinic for injection, followed by a short-term wear period in-clinic for injection, and finally during a 27hr in-clinic stay for injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-clinic wear first | Device | Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Device Performance - Dose delivery efficiency | Determined by volume - measured via gravimetric analysis (weighing the device) | After device removal |
| Device Performance | Change in adhesive pad adherence - device to skin/device to adhesive pad - determined via adherence scales (Score 0 - 4, whereby 0 is full adherence and 4 is reflecting full detachment) | From device application until 15-minutes after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Additional OBI performance - Injection signal/indicator performance | Assessed by visual or audible observation from activation to injection end. | Before, during and after injection for each applied device; up to 28 hours after application |
| Additional OBI performance - Catheter condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yves Donazzolo, MD | Eurofins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Optimed | Gières | France |
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All participants will participate in three (3) study arms, whereby each participant will wear six (6) OBI prototype devices in total: three (3) on the arm and three (3) on the abdomen. A randomization scheme will be provided with the order of study arm + body location (arm/abdomen) + body side (left/right) randomized.
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| Home wear first | Device | Device will be applied to the abdomen or arm to deliver placebo subcutaneously. After device application, participant will go home and return to clinic before delivery. |
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Catheter bending assessment by grading |
| Approximately 15-minutes after device removal |
| Participant Pain | 100mm Visual Analog Scale (VAS) for pain assessment - describing no pain with 0mm - up to worst possible pain described with 100mm | Immediately before device catheter is inserted, after insertion, during wear period, at start of injection, 15 minutes after injection, end of injection and upon removal for each applied device |
| Participant Acceptability Questionnaires | Questionnaires to assess participants' acceptability of the device during wear | Device acceptability questionnaire will be completed after device catheter is inserted, at 8 hours and 26 hrs after application, during Injection and upon device removal |
| Ultrasound Imaging of injection site | Measure pre- and post-injection tissue thickness | Baseline and immediately after procedure for each applied device |
| Tissue Effects | Assessment of wheal and erythema described via grading 0-4, incidence of bleeding, bruising, induration | Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present |
| Adverse Events | Incidence of adverse device effects and procedure related adverse events | Throughout study completion, an average of 4 week |