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)

SQ Innovation, Inc.60 enrolled

Overview

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.

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 the Infusor by study staff with photographic recording prior to and after removal. Group B (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and photographic recording of the Infusor by study staff after which the subject will return home and removal of the Infusor by subject or caregiver approximately 12hrs after placement (± 1hr), when another photograph will be taken. The subject must return the device to the site and transfer the photograph in accordance with the instructions. Until enrollment for Group B is complete, study candidates will be asked if prefer group A or B. Additional inclusion criteria apply for participation in group B. Consent, screening and enrollment may be performed on the same day (Day 1) Screening must be performed within 7 days of the Wear phase. Following signing of the ICF (A or B) each subject will complete Screening activities (height, weight, brief medical history). If the subject meets all inclusion criteria an none of the exclusion criteria the subject may enroll. The Wear Phase consists of one (1) wear period of five to twelve (5-12) hours.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 5-9 hours

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

Time frame: > 5 hours

Secondary Outcomes

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.

Time frame: 5-12 hours

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.

Time frame: 5-12 hours

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.

Time frame: 5-12 hours

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)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes