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NCT04836572 · ClinicalTrials.gov registry record · NA
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)
A NA study of Healthy Volunteer Study, sponsored by SQ Innovation.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04836572: Completed NA study of Healthy Volunteer Study, sponsored by SQ Innovation.
NCT04836572 is a NA study of Healthy Volunteer Study that has completed, run by SQ Innovation. The registered enrollment target is 60 participants, above the 30-participant average among 9 other Healthy Volunteer Study trials with a reported enrollment target (100% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04836572, a NA study of Healthy Volunteer Study, has completed, sponsored by SQ Innovation.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER 3M 1529 Adhesive Tape
Study Locations (1)
Massachusetts
- Community Clinical Research Network - Marlborough
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-01-20 |
| Est. Completion | 2021-03-04 |
| Phase | NA |
What the finished NCT04836572 record still lists
NCT04836572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 30-participant average among 9 other Healthy Volunteer Study trials with a reported enrollment target (100% higher).
The record links to 1 condition, with Healthy Volunteer Study appearing as the primary indexed condition, and to 1 intervention - of which 3M 1529 Adhesive Tape is the first listed.
NCT04836572 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04836572 about?
NCT04836572 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT04836572?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2021-01-20. Estimated completion is 2021-03-04.
What conditions does trial NCT04836572 study?
This clinical trial studies the following conditions: Healthy Volunteer Study.
What interventions are being tested in trial NCT04836572?
The interventions under investigation include: 3M 1529 Adhesive Tape (OTHER).
Who is sponsoring clinical trial NCT04836572?
This trial is sponsored by SQ Innovation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04836572 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04836572's enrollment target sits among peer trials
60 2nd of 9 the highest of 9 other Healthy Volunteer Study trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer Study trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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