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A Single Arm sTudy to Evaluate the Effectiveness of EndoAVF in a Pre-dialysis Population (STEP Study)

NCT04633304 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-02-09

No results posted yet for this study

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).

Conditions

  • CKD Stage 3
  • CKD Stage 4
  • CKD Stage 5

Interventions

DEVICE

EndoAVF System for endovascular AV fistula creation

AV fistula creation

Sponsors & Collaborators

  • California Institute of Renal Research

    lead OTHER

Principal Investigators

  • Osman Khawar, MD · California Institute of Renal Research

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2023-12-15
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633304 on ClinicalTrials.gov