Healthy Volunteer Study Clinical Trial
Official title:
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)
Verified date | July 2021 |
Source | SQ Innovation, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 4, 2021 |
Est. primary completion date | March 4, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | Inclusion Criteria: - Subjects will be considered for inclusion only if they meet all of the following criteria: 1. An Institutional Review Board (IRB)-approved informed consent is signed and dated prior to any study-related activities. 2. Male and female subjects =40 and =80 years of age 3. Body mass index (BMI) <38 kg/m2. 4. Females will be non-pregnant and non-lactating. 5. Able to participate in the study in the opinion of the Investigator. 6. Has the ability to understand the requirements of the study and is willing to comply with all study procedures. Exclusion Criteria: - Subjects will be excluded from participation if they meet any of the following criteria: 1. Systolic blood pressure (SBP) <90 mmHg. 2. Temperature =38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment. 3. History of COVID-19 infection or recent exposure to someone with COVID-19 or who is currently in quarantine for COVID-19 exposure. 4. Presence of signs or symptoms of possible COVID-19 infection, including cough, shortness of breath, or temperature = 38°C. 5. Previous abdominal surgery resulting in presence of a scar or malformation in upper abdominal area. 6. Presence of skin disorder or abnormality in upper abdominal area. 7. Known or suspected allergy to acylate adhesives or other materials present in the device. 8. Significant comorbidities or health issues which in the opinion of the investigator may interfere with study participation or study assessments. 9. Major surgery within 30 days prior to Screening. 10. Administration of an investigational drug or implantation of investigational device, or participation in another interventional trial, within 30 days prior to Screening. |
Country | Name | City | State |
---|---|---|---|
United States | Community Clinical Research Network | Marlborough | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
SQ Innovation, Inc. | Community Clinical Research Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adhesion | Number of participants with failed adhesion (Adhesion Score of 3 or 4 - Appendix A) 5-9 hours after placement as determined by study staff and documented by photography. | 5-9 hours | |
Primary | Re-adhesion | Number of participants with successful re-adhesion - score of 0, 1 or 2 as per Appendix A at 5 minutes after adhesion at the opposite side of the upper abdomen after a completed simulated wear period of no less than 5 hours | > 5 hours | |
Secondary | Comfort of Wear | Overall average comfort of wear score of the test device using a 10-point Visual Analogue Scale (VAS). The scores are values 0-10, with 0 being very comfortable, and 10 being intolerable discomfort. | 5-12 hours | |
Secondary | Interference | Overall average scoring of interference with important routine activities of daily living such as use of the bathroom, walking, and climbing stairs using a 10-point Visual Analogue Scale (VAS). The scores are values are 0-10, with 0 being no interference, and 10 being great interference. | 5-12 hours | |
Secondary | Irritation | Overall average irritation score for erythema and edema (on a 5-point scale) after wear(Appendix C). The scores are values 0-4 with 0 being no erythema/edema, and 4 being severe erythema/edema. | 5-12 hours |
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