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| ID | Type | Description | Link |
|---|---|---|---|
| J3G-MC-S004 | Other Identifier | Eli Lilly and Company |
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This is a device feasibility study designed to evaluate the practicality of delivering a high-viscosity solution subcutaneously using various injection parameters, including volume, rate, and needle length. The goal is to assess the usability and operational performance of a delivery setup (Havard apparatus syringe pump and related components) to inform design requirements for future large-volume injection devices.
No active drug is administered in this study, and no health outcomes are being evaluated.
The study duration is approximately 40 days, including screening, injection assessments, and follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (ABHCGDFE) | Experimental | Syringe pump is used to subcutaneously (SC) administer buffer solution with hyaluronic acid as a viscosity agent |
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| Sequence 2 (BCADHEGF) | Experimental | Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
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| Sequence 3 (CDBEAFHG) | Experimental | Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
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| Sequence 4 (DECFBGAH) | Experimental | Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
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| Sequence 5 (EFDGCHBA) | Experimental | Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
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| Sequence 6 (FGEHDACB) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvard Apparatus syringe pump | Device | Used to administer buffer solution with hyaluronic acid SC. |
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| Measure | Description | Time Frame |
|---|---|---|
| Usability Assessment of Subcutaneous Injections Using a Syringe Pump Across Multiple Delivery Parameters | Usability will be assessed by evaluating the proportion of subcutaneous injections administered using Harvard Apparatus syringe pump across varying injection volumes, rates, and needle lengths. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea CRU, Inc. | Dallas | Texas | 75247 | United States |
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| Experimental |
Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
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| Sequence 7 (GHFAEBDC) | Experimental | Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
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| Sequence 8 (HAGBFCED) | Experimental | Syringe pump is used to SC administer buffer solution with hyaluronic acid as a viscosity agent |
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