Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06385249
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-17
Brief Title:
An Evaluation of Navina Mini a New Trans-anal Irrigation TAI Device in Children and Adolescents
Sponsor:
Wellspect HealthCare
Organization:
Wellspect HealthCare
Study Overview
Official Title:
An Uncontrolled Prospective Multicenter Post-market Clinical Investigation to Confirm the Performance and Safety of Navina Mini a New CE-marked Low-volume Trans-anal Irrigation TAI Device in Children and Adolescents
Status:
RECRUITING
Status Verified Date:
2024-04
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 study is designed to deliver further information on clinical benefit patients satisfaction and perception of handling and to confirm safety of Navina Mini when used in children and adolescents
Detailed Description:
This is an uncontrolled prospective multicentre post-market clinical follow-up investigation that will enroll male and female children adolescents with a need for low-volume transanal irrigation TAI as judged by the investigator or designee
A total of 27 subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four 4 to six 6 weeks
The study is designed to deliver further information on clinical benefit patients satisfaction and perception of handling and to confirm device safety when used in children and adolescents
A total of 27 subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four 4 to six 6 weeks
The study is designed to deliver further information on clinical benefit patients satisfaction and perception of handling and to confirm device safety when used in children and adolescents
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