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NCT02772146

A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure

Terminated NA Last updated 14 March 2017
What this trial tests

NA trial testing CLS UF in Heart Failure in 2 participants. Terminated before completion.

Timeline
11 May 2016
Primary endpoint
23 January 2017
23 January 2017

Quick facts

Lead sponsorTriomed AB
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment2
Start date11 May 2016
Primary completion23 January 2017
Estimated completion23 January 2017
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Triomed AB — full company profile →

Who can join

Adults 18 to 80, any sex, with Heart Failure or Cardio-Renal Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours. The device will be connected to an existing, standard PD catheter that the patient will be using routinely prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study). The patient will be hospitalized for observation during the test day and during the night following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood glucose concentrations as well the patient's acceptability and tolerance of the wearable device will be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Heart Failure

Currently open trials in the same condition.

Other Triomed AB trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02772146.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing