Viewing Study NCT04836572



Ignite Creation Date: 2024-05-06 @ 3:59 PM
Last Modification Date: 2024-10-26 @ 2:01 PM
Study NCT ID: NCT04836572
Status: COMPLETED
Last Update Posted: 2021-07-21
First Post: 2021-03-31

Brief 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
Sponsor: SQ Innovation Inc
Organization: SQ Innovation Inc

Study Overview

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
Status: COMPLETED
Status Verified Date: 2021-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 hold performance re-use protection ie adhesive re-application and skin reactivitytolerability of the proposed commercial adhesive tape ie 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None