Investigational On-body Injector Clinical Study

Sponsor

Becton, Dickinson and Company (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05553418

Collaborator

(none)

Enrollment

Location

Arms

8.8

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Device: In-clinic wear first Device: Home wear first	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 5, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: "In-Clinic wear first" 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.	Device: In-clinic wear first Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection
Experimental: "Home wear first" 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	Device: 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.

Arm

Intervention/Treatment

Experimental: "In-Clinic wear first"

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.

Device: In-clinic wear first

Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection

Experimental: "Home wear first"

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

Device: 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.

Outcome Measures

Primary Outcome Measures

Device Performance - Dose delivery efficiency [After device removal]
Determined by volume - measured via gravimetric analysis (weighing the device)
Device Performance [From device application until 15-minutes after injection]
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)

Secondary Outcome Measures

Additional OBI performance - Injection signal/indicator performance [Before, during and after injection for each applied device; up to 28 hours after application]
Assessed by visual or audible observation from activation to injection end.
Additional OBI performance - Catheter condition [Approximately 15-minutes after device removal]
Catheter bending assessment by grading
Participant Pain [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]
100mm Visual Analog Scale (VAS) for pain assessment - describing no pain with 0mm - up to worst possible pain described with 100mm
Participant Acceptability Questionnaires [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]
Questionnaires to assess participants' acceptability of the device during wear
Ultrasound Imaging of injection site [Baseline and immediately after procedure for each applied device]
Measure pre- and post-injection tissue thickness
Tissue Effects [Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present]
Assessment of wheal and erythema described via grading 0-4, incidence of bleeding, bruising, induration
Adverse Events [Throughout study completion, an average of 4 week]
Incidence of adverse device effects and procedure related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurofins Optimed	Gières		France

Sponsors and Collaborators

Becton, Dickinson and Company

Investigators

Principal Investigator: Yves Donazzolo, MD, Eurofins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Becton, Dickinson and Company

ClinicalTrials.gov Identifier:

NCT05553418

Other Study ID Numbers:

PHS-20OBI01

First Posted:

Sep 23, 2022

Last Update Posted:

Sep 23, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Becton, Dickinson and Company

On-Body Injector

Study Results

No Results Posted as of Sep 23, 2022