An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device)
Completed · Not applicable
Conditions studied: Healthy Volunteer Study
In brief
The purpose of the present study is to test the adequacy, performance and skin reactivity of the adhesive tape to be utilized in the to-be-marketed Device. The present study will examine adhesive hold performance, re-use protection (i.e. adhesive re-application) and skin reactivity/tolerability of the proposed commercial adhesive tape (i.e. within the Test Infusor Device; TID). As the purpose of the study is to assess adhesive performance which does not require activation of the device. Hence in this study no canula will be deployed (no skin penetration) and no delivery of the drug or other fluids.
Key facts
- Study ID
- NCT04836572
- Run by
- SQ Innovation, Inc.
- People needed
- 60
- Starts
- 2021-01-20
- Expected to finish
- 2021-03-04
- Last updated by the study team
- 2021-07-21
Who can join
Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects will be considered for inclusion only if they meet all of the following criteria:
- An Institutional Review Board (IRB)-approved informed consent is signed and dated prior to any study-related activities.
- Male and female subjects ≥40 and ≤80 years of age
- Body mass index (BMI) <38 kg/m2.
- Females will be non-pregnant and non-lactating.
- Able to participate in the study in the opinion of the Investigator.
- Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
You may not qualify if…
- Subjects will be excluded from participation if they meet any of the following criteria:
- Systolic blood pressure (SBP) <90 mmHg.
- Temperature ≥38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.
- History of COVID-19 infection or recent exposure to someone with COVID-19 or who is currently in quarantine for COVID-19 exposure.
- Presence of signs or symptoms of possible COVID-19 infection, including cough, shortness of breath, or temperature ≥ 38°C.
- Previous abdominal surgery resulting in presence of a scar or malformation in upper abdominal area.
- Presence of skin disorder or abnormality in upper abdominal area.
- Known or suspected allergy to acylate adhesives or other materials present in the device.
- Significant comorbidities or health issues which in the opinion of the investigator may interfere with study participation or study assessments.
- Major surgery within 30 days prior to Screening.
- Administration of an investigational drug or implantation of investigational device, or participation in another interventional trial, within 30 days prior to Screening.
Where it is running
- Community Clinical Research Network — Marlborough, Massachusetts, United States
Full record on ClinicalTrials.gov
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