Status:
COMPLETED
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)
Lead Sponsor:
SQ Innovation, Inc.
Collaborating Sponsors:
Community Clinical Research Network
Conditions:
Healthy Volunteer Study
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 hol...
Detailed Description
An open-label, non significant risk, adhesive wear validation study with 60 adult subjects. Group A (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and subsequent removal of t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04836572
Start Date
January 20 2021
End Date
March 4 2021
Last Update
July 21 2021
Active Locations (1)
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1
Community Clinical Research Network
Marlborough, Massachusetts, United States, 01752