Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633304
Status:
RECRUITING
Last Update Posted:
2023-02-09
First Post:
2020-10-09
Brief Title:
A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population STEP Study
Sponsor:
California Institute of Renal Research
Organization:
California Institute of Renal Research
Study Overview
Official Title:
A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population
Status:
RECRUITING
Status Verified Date:
2023-02
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 investigator-initiated post-marketing study that will evaluate use of the WaveLinQ system a new and novel method of fistula creation using a percutaneous method in patients who require the creation of an arteriovenous fistula AVF
Detailed Description:
This investigator-initiated post-marketing study will evaluate use of the WaveLinQ system a new and novel method of fistula creation which uses a percutaneous method to create an AVF Thirty male and female subjects with CKD 3-5 and who are clinical indicated for arteriovenous fistula AVF creation will be enrolled using the WaveLinQ device Eligibility confirmation will be confirmed during screening up to 28 days from the index procedure Subjects who are eligible will undergo fistula creation per standard institutional technique indexbaseline and be followed at least monthly for 6 months per their standard of care plan Primary clinical and functional patency will be observed throughout the trial in addition to other data collection points per protocol The expected total duration of subject participation from screening until the end of study is up to 7 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None