Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2025-12-17 @ 1:23 AM
Study NCT ID:
NCT04836572
Status:
None
Last Update Posted:
2021-07-21 00:00:00
First Post:
2021-03-31 00:00:00
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:
None
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:
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.
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.
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
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