Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377280
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-09-28
Brief Title:
En Evaluation of Navina Mini a New Low-volume Transanal Irrigation Device
Sponsor:
Wellspect HealthCare
Organization:
Wellspect HealthCare
Study Overview
Official Title:
An Un-controlled Prospective Multi-center Post Market Clinical Follow-up Investigation to Confirm Performance and Safety of Navina Mini a New CE-marked Low-volume Transanal Irrigation TAI Device
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:
This is an un-controlled prospective multi center post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation TAI as judged by the investigator A total of 40 investigational 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 during a period of four weeks
Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks The first visit Visit 1 will be performed at the investigational clinic to assess eligibility collect demographics baseline data and instruct how to use the device Visit 2 will be performed after two weeks of treatment through telephone contact The final visit Visit 3 will be performed after additional two weeks of treatment and can be performed either at the investigational clinic or through telephone contact
Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks The first visit Visit 1 will be performed at the investigational clinic to assess eligibility collect demographics baseline data and instruct how to use the device Visit 2 will be performed after two weeks of treatment through telephone contact The final visit Visit 3 will be performed after additional two weeks of treatment and can be performed either at the investigational clinic or through telephone contact
Detailed Description:
None
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