Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247644
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2023-12-18
Brief Title:
BD Evolve On-body Injectors Adherence Performance - Wear Study
Sponsor:
Becton Dickinson and Company
Organization:
Becton Dickinson and Company
Study Overview
Official Title:
Clinical Study of the BD Evolve On-body Injectors Adherence Performance on the Arm Over 28 Hours of Wear
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An On-body Injector is a small device which is adhered to the skin with a sticky patch The injector is intended to deliver a small volume of medicine from a reservoir inside the device into the skin via a small catheter The drug delivery happens after a period of time as programmed into the device and afterwards the device can be removed
The purpose of this study is to evaluate how well the BD Evolve On-body Injector adhesive pad sticks to the skin and how the adhesive keeps the device in position when worn on the arm during normal daily activities for 28 hours As this study only evaluates the performance of the adhesive pad of the OBI no injection will be performed and the device will not be filled with any fluid The injection capability will be disabled
The purpose of this study is to evaluate how well the BD Evolve On-body Injector adhesive pad sticks to the skin and how the adhesive keeps the device in position when worn on the arm during normal daily activities for 28 hours As this study only evaluates the performance of the adhesive pad of the OBI no injection will be performed and the device will not be filled with any fluid The injection capability will be disabled
Detailed Description:
The BD Evolve On-body Injector OBI is being developed as a platform drug delivery device for use with a class or family of drug products approved for subcutaneous injections It is a small fill-at-use device based on a core BD technology for wearable pump drug delivery systems
The OBI is a sterile single-use single-dose disposable wearable pump injector that delivers a fixed dose of 06ml of drug approximately 27 hours after the device is activated the dose will be delivered subcutaneously over a duration of 35 minutes in the home environment
The purpose of this study is to assess the adherence performances adhesive pad to participants skin and heat stake of the BD Evolve On-body injector OBI when worn on the arm for 28 hours under normal daily activities in generally healthy human subjects with and without use of an additional adhesive ring Cutaneous tissue effects associated with wear of the OBI device with and without use of an additional adhesive ring will also be assessed
The OBI is a sterile single-use single-dose disposable wearable pump injector that delivers a fixed dose of 06ml of drug approximately 27 hours after the device is activated the dose will be delivered subcutaneously over a duration of 35 minutes in the home environment
The purpose of this study is to assess the adherence performances adhesive pad to participants skin and heat stake of the BD Evolve On-body injector OBI when worn on the arm for 28 hours under normal daily activities in generally healthy human subjects with and without use of an additional adhesive ring Cutaneous tissue effects associated with wear of the OBI device with and without use of an additional adhesive ring will also be assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None