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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)

NCT04836572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-07-21

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer Study

Interventions

OTHER

3M 1529 Adhesive Tape

5-12 hour adhesive wear

Sponsors & Collaborators

  • Community Clinical Research Network

    collaborator UNKNOWN

  • SQ Innovation, Inc.

    lead INDUSTRY

Principal Investigators

  • Kyle Magner, RN · Community Clinical Research Network

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2021-03-04
Completion
2021-03-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04836572 on ClinicalTrials.gov