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
|ClinicalTrials.gov Identifier: NCT02772146|
Recruitment Status : Terminated (After 2 patients it was concluded that a large change in exclusion criteria and study design was needed to obtain the ojective for the study)
First Posted : May 13, 2016
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Cardio-Renal Syndrome||Device: CLS UF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Actual Study Start Date :||May 11, 2016|
|Actual Primary Completion Date :||January 23, 2017|
|Actual Study Completion Date :||January 23, 2017|
Experimental: Device: CLS UF
The purpose of CLS UF is ultrafiltration and drain of excess fluid in patients with congestive heart failure. The function of the device is to extra corporeally recirculate profiled glucose based PD fluid in a system and maintain glucose levels by adding extra glucose, to an adjustable and constant level, in order to maintain a stable ultrafiltration.
Device: CLS UF
One single ultrafiltration session of 10 hours.
Other Name: Carry LifeTM System Ultra Filtration
- Ultrafiltrated volume [ Time Frame: 10 hours ]Ultrafiltrated volume during a 10 hours study session.
- Any Adverse Event (AE), Serious Adverse Event (SAE), Adverse Device Effect (ADE) or Serious Adverse Device Effect (SADE) occurring during the study session and until the follow-up visit. [ Time Frame: 2-4 weeks ]
- Patient acceptance of the wearable device [ Time Frame: 10 hours ]Subjective opinion of each patient
- Measured glucose levels in the re-circulated PD fluid [ Time Frame: 10 hours ]
- Patients acceptability of the re-circulation of PD fluid [ Time Frame: 10 hours ]Any abdominal symptoms of the drain and fill of PD fluid will be recorded.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772146
|Division of Nephrology, Heidelberg University Hospital|
|Heidelberg, Germany, 69120|
|Principal Investigator:||Christian Morath, PD Dr. Med||Division of Nephrology, Heidelberg University Hospital, Germany|