Skip to main content
OpenTrials
Completed

NCT Number: NCT05553418

Investigational On-body Injector Clinical Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Optimed

Gières, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-clinic wear first

Device

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

Home wear first

Device

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.

Primary outcomes

  1. Device Performance - Dose delivery efficiency

    Time frame: After device removal

    Determined by volume - measured via gravimetric analysis (weighing the device)

  2. Device Performance

    Time frame: 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 outcomes

  1. Additional OBI performance - Injection signal/indicator performance

    Time frame: 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.

  2. Additional OBI performance - Catheter condition

    Time frame: Approximately 15-minutes after device removal

    Catheter bending assessment by grading

  3. Participant Pain

    Time frame: 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

  4. Participant Acceptability Questionnaires

    Time frame: 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

  5. Ultrasound Imaging of injection site

    Time frame: Baseline and immediately after procedure for each applied device

    Measure pre- and post-injection tissue thickness

  6. Tissue Effects

    Time frame: 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

  7. Adverse Events

    Time frame: Throughout study completion, an average of 4 week

    Incidence of adverse device effects and procedure related adverse events

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 23, 2022
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.