An Open-label, Non Significant Risk, Adhesive Wear Validation Study for

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Healthy Volunteer Study

Clinical Trial Details

NCT number	NCT04836572
Study type	Interventional
Source	SQ Innovation, Inc.
Contact
Status	Completed
Phase	N/A
Start date	January 20, 2021
Completion date	March 4, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms