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Non Invasive External Monitoring in Dialysis Patients (FARM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919438
First Posted: June 12, 2009
Last Update Posted: February 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Corventis, Inc.
  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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919438


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

Responsible Party: Madhuri Bhat VP, Regulatory and Clinical Affairs, Corventis
ClinicalTrials.gov Identifier: NCT00919438     History of Changes
Other Study ID Numbers: COR-2008-001
First Submitted: June 10, 2009
First Posted: June 12, 2009
Last Update Posted: February 4, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases


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