RECRUITING

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

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Conditions

CKD Stage 3CKD Stage 4CKD Stage 5CKD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2020-12-15
Study Completion:2023-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04633304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or Female Age of at least 18 years
  2. 2. CKD 3 through 5 as measured by GFR 45 and under by MDRD equation on two separate occasions at least 3 months apart.
  3. 3. Provide written informed consent using a form that is approved by the Institutional Review Board (IRB) prior to collection of study data or performance of study procedures.
  4. 4. Currently not on hemodialysis.
  5. 5. Life expectancy of at least one year
  6. 6. Meets Anatomical Criteria for EndoAVF creation via pre-procedure Duplex or Venography Vascular anatomy suitable for creation of the AV fistula
  7. 7. Willing to comply with the specified follow-up evaluations
  1. 1. Anatomical exclusion criteria met
  2. 2. Thought to need dialysis within 30 days.
  3. 3. The subject is in a hypercoagulable state.
  4. 4. The subject has known bleeding diathesis.
  5. 5. The subject has insufficient cardiac output to support a native fistula in the opinion of the investigator.
  6. 6. Known history of active intravenous drug abuse.
  7. 7. The subject has a known allergy or hypersensitivity to contrast media which cannot be adequately pre-medicated.
  8. 8. The subject has known adverse effects to sedation and/or anesthesia which cannot be adequately pre-medicated.
  9. 9. Evidence of active infection on the day of the index procedure (temperature of ≥ 38.0° Celsius and/ or WBC of ≥ 12,000 cells/ μL, if collected).

Contacts and Locations

Study Contact

Osman Khawar, MD
CONTACT
7602943162
okhawar@bnmg.org
Michael Gastauer
CONTACT
8588108155
mgastauer@balboaunited.org

Principal Investigator

Osman Khawar, MD
PRINCIPAL_INVESTIGATOR
California Institute of Renal Research

Study Locations (Sites)

California Institute of Renal Research
Escondido, California, 92027
United States

Collaborators and Investigators

Sponsor: California Institute of Renal Research

  • Osman Khawar, MD, PRINCIPAL_INVESTIGATOR, California Institute of Renal Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-15
Study Completion Date2023-12-31

Study Record Updates

Study Start Date2020-12-15
Study Completion Date2023-12-31

Terms related to this study

Keywords Provided by Researchers

  • CKD

Additional Relevant MeSH Terms

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