Healthy VolunteersNCT05553418
Investigational On-body Injector Clinical Study
A study testing In-clinic wear first and Home wear first in people with Healthy Volunteers, run by Becton, Dickinson and Company at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- In-clinic wear first and Home wear first
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2022to 8 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BD Evolve On-body Injector: Clinical Feasibility and Performance in the Abdomen and Arm
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- In-clinic wear first, Home wear first
- Keywords
- On-Body Injector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-clinic wear firstDevice
Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection
Home wear firstDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| "In-Clinic wear first" | Experimental | 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. Receives: Device: In-clinic wear first |
| "Home wear first" | Experimental | 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 Receives: Device: Home wear first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Performance - Dose delivery efficiency
Determined by volume - measured via gravimetric analysis (weighing the device)
Measured: After device removal
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)
Measured: From device application until 15-minutes after injection
Secondary outcomes (7)
Additional OBI performance - Injection signal/indicator performance
Assessed by visual or audible observation from activation to injection end.
Measured: Before, during and after injection for each applied device; up to 28 hours after application
Additional OBI performance - Catheter condition
Catheter bending assessment by grading
Measured: Approximately 15-minutes after device removal
Participant Pain
100mm Visual Analog Scale (VAS) for pain assessment - describing no pain with 0mm - up to worst possible pain described with 100mm
Measured: 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
Participant Acceptability Questionnaires
Questionnaires to assess participants' acceptability of the device during wear
Measured: 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
Ultrasound Imaging of injection site
Measure pre- and post-injection tissue thickness
Measured: Baseline and immediately after procedure for each applied device
Tissue Effects
Assessment of wheal and erythema described via grading 0-4, incidence of bleeding, bruising, induration
Measured: Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present
Adverse Events
Incidence of adverse device effects and procedure related adverse events
Measured: Throughout study completion, an average of 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start5 Sep 2022
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Donazzolo, MD, Principal investigator, Eurofins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553418
- Sponsor's protocol ID
- PHS-20OBI01
- Status last verified
- Jan 2025
- First submitted
- 15 Jul 2022
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BD Evolve On-body Injector: Clinical Feasibility and Performance in the Abdomen and Arm
- ClinicalTrials.gov ID
- NCT05553418
- Acronym / sponsor ID
- PHS-20OBI01
- Conditions
- Healthy Volunteers
- Keywords
- On-Body Injector
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| "In-Clinic wear first" | Experimental | Device: In-clinic wear firstParticipant 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. |
| "Home wear first" | Experimental | Device: Home wear firstParticipant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-clinic wear firstParticipant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection | Device | "In-Clinic wear first" |
| Home wear firstDevice 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. | Device | "Home wear first" |
Primary outcome
Device Performance - Dose delivery efficiency
Time frame: After device removal
Determined by volume - measured via gravimetric analysis (weighing the device)
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)
7 secondary outcomes
Additional OBI performance - Injection signal/indicator performance
Time frame: Before, during and after injection for each applied device; up to 28 hours after application
Additional OBI performance - Catheter condition
Time frame: Approximately 15-minutes after device removal
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
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
Ultrasound Imaging of injection site
Time frame: Baseline and immediately after procedure for each applied device
Tissue Effects
Time frame: Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present
Adverse Events
Time frame: Throughout study completion, an average of 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Donazzolo, MD principal investigator
Eurofins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-clinic wear first and Home wear first in people with Healthy Volunteers, run by Becton, Dickinson and Company at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Performance - Dose delivery efficiency (time frame: After device removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.