NCT04836572

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: SQ Innovation, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

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 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.

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 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.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
OTHER	3M 1529 Adhesive Tape	5-12 hour adhesive wear

Timeline

• Start date: 2021-01-20
• Primary completion: 2021-03-04
• Completion: 2021-03-04
• First posted: 2021-04-08
• Last updated: 2021-07-21

Locations

1 site across 1 country: United States