Non Invasive External Monitoring in Dialysis Patients (FARM)

This study has been completed.
Sponsor:
Information provided by:
Corventis, Inc.
ClinicalTrials.gov Identifier:
NCT00919438
First received: June 10, 2009
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

This is a single center, non randomized study to gather data to correlate physiological signals with the patient's fluid status during fluid removal in hemodialysis.


Condition Intervention
Kidney Failure
Device: AVIVO™ Mobile Patient Management System

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Fluid Removal During Adherent Renal Monitoring

Resource links provided by NLM:


Further study details as provided by Corventis, Inc.:

Estimated Enrollment: 25
Study Start Date: January 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dialysis Device: AVIVO™ Mobile Patient Management System
Non Invasive monitoring device
Other Name: Diuretics- oral or IV

Detailed Description:

Patients undergoing hemodialysis will be monitored with the study device . The collected information will be correlated with fluid loss.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care and kidney failure clinics

Criteria

Inclusion Criteria:

  • Is female or male, 18 years of age or older
  • Undergoing hemodialysis for fluid removal

Exclusion Criteria:

  • Is participating in another clinical study that may confound the results of this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919438

Sponsors and Collaborators
Corventis, Inc.
Investigators
Principal Investigator: Inder Anand, MD VAMC, MN
Study Director: Imad Libbus, PhD Corventis, Inc.
  More Information

No publications provided

Responsible Party: Madhuri Bhat VP, Regulatory and Clinical Affairs, Corventis
ClinicalTrials.gov Identifier: NCT00919438     History of Changes
Other Study ID Numbers: COR-2008-001
Study First Received: June 10, 2009
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014