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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05553418
Other study ID # PHS-20OBI01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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