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Arm 1 - On-body Injector (OBI) - only for Healthy Subjects
N/A
Waitlist Available
Led By Jesson Yeh, MD
Research Sponsored by Becton, Dickinson and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy male or female participants ≥ 18 years of age, without evidence of acute illness
Participant with a BMI ≥18.5 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during wear period of 28 hours
Awards & highlights
Study Summary
"This trial is testing how well a small device called the BD Evolve™ On-body Injector sticks to the skin when worn on the arm during daily activities for 28 hours. The device is meant to
Who is the study for?
This trial is for healthy adults over 18 years old with a BMI of at least 18.5, who can read and understand English, and are willing to follow study procedures. They must consent to potentially having hair clipped where the device will be placed and agree to wear a loose short-sleeved shirt during visits.Check my eligibility
What is being tested?
The BD Evolve™ On-body Injector (OBI) is being tested for its ability to stick on the skin without delivering any medicine. Participants will wear this device on their arm for 28 hours while doing normal activities to see how well it stays in place.See study design
What are the potential side effects?
Since no medication is delivered in this study, side effects may be limited to potential skin irritation or allergic reaction from the adhesive pad used by the OBI.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older and currently healthy without any signs of acute illness.
Select...
My BMI is 18.5 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during wear period of 28 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during wear period of 28 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence Performance
Secondary outcome measures
Skin effects
Other outcome measures
Safety - Adverse device effects
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 - OBI + additional adhesive ringExperimental Treatment1 Intervention
Adhesion of device with adhesive on left or right upper arm + additional adhesive ring to be placed additional on the skin.
Group II: Arm 1 - On-body Injector (OBI) - onlyExperimental Treatment1 Intervention
Adhesion of device with adhesive on left or right upper arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Device wear on skin
2024
N/A
~130
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Who is running the clinical trial?
Becton, Dickinson and CompanyLead Sponsor
70 Previous Clinical Trials
88,458 Total Patients Enrolled
Jesson Yeh, MDPrincipal InvestigatorTKL Research, Inc.
1 Previous Clinical Trials
64 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients currently being enrolled in this ongoing clinical trial?
"As documented on clinicaltrials.gov, the current trial is actively pursuing eligible participants. It was first listed on 2/14/2024 and most recently revised on 2/26/2024."
Answered by AI
What is the current number of participants being admitted to this clinical study?
"Affirmative. The information on clinicaltrials.gov confirms the active recruitment status of this trial, initially posted on February 14th, 2024 and updated most recently on February 26th, 2024. This study aims to enroll a total of 126 participants at one designated site."
Answered by AI
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