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Hemodialysis Access Surveillance Evaluation Study

NCT02376361 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2021-02-23

Study results available
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Summary

The purpose of the study is to learn if monitoring dialysis access blood flow during dialysis treatment with a transonic machine (an ultrasound technique) will prevent (or reduce) the development of dialysis access thrombosis (clotting).

Investigators would like to study if monitoring with a specific technique called ultrasound dilution technique can help prevent problems with access when compared to what is the current standard of care for patients.

Conditions

Interventions

DEVICE

Transonic

Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system). 1. Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines 2. Recirculation, access flow will be performed according to HD03 Manual. 3. Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist.

Sponsors & Collaborators

  • Transonic Systems Inc.

    collaborator INDUSTRY

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Loay Salman, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02376361 on ClinicalTrials.gov