Investigational On-body Injector Clinical Study

Healthy Volunteers Clinical Trial

Official title:

BD Evolve On-body Injector: Clinical Feasibility and Performance in the Abdomen and Arm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05553418
• Other study ID #: PHS-20OBI01
• Status: Completed
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: February 8, 2023

Study information

• Verified date: January 2024
• Source: Becton, Dickinson and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy adult participants = 18 years

• BMI =18.5 kg/m2

• Participant willing and able to complete all required study procedures and to provide informed consent

Exclusion Criteria:

• Participant any self-reported existing chronic illness (heart disease, respiratory disease, kidney disease, metabolic diseases etc.).

• Participants with treatment interfering with coagulation, platelet function, or pain perception within 12 hrs of in-clinic visit

• Participants with abdominal or arm skin conditions or treatments that may interfere with planned study treatment

• Participants with acute or chronic hepatitis B or C and/or with known history/positive HIV serology.

• Participants who are pregnant, planning to become pregnant, or are breast-feeding.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• In-clinic wear first
Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection
• Home wear first
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.

Locations

Country	Name	City	State
France	Eurofins Optimed	Gières

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Performance - Dose delivery efficiency	Determined by volume - measured via gravimetric analysis (weighing the device)	After device removal
Primary	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
Secondary	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
Secondary	Additional OBI performance - Catheter condition	Catheter bending assessment by grading	Approximately 15-minutes after device removal
Secondary	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
Secondary	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
Secondary	Ultrasound Imaging of injection site	Measure pre- and post-injection tissue thickness	Baseline and immediately after procedure for each applied device
Secondary	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
Secondary	Adverse Events	Incidence of adverse device effects and procedure related adverse events	Throughout study completion, an average of 4 week