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
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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
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Condition or disease | Intervention/treatment | Phase |
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Heart Failure Cardio-Renal Syndrome | Device: CLS UF | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
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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.
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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.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patient, 18-80 years of age.
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Prevalent PD patients with CHF with cardio-renal syndrome type II, on stable ultrafiltration, for more than two months, treated with PD based UF according to German national guidelines.
- Therapy resistance of pharmacologic therapy: resistant hypervolemia with ascites, pleural fluid and pulmonary edema
- Recurrent hospitalization with cardiac decompensation, ≥ 2 occasions during the last six months
- Isolated failure of the right heart chamber
- Treatment based on night time APD therapy combined with a day time long dwell.
- Obtained written consent to participate in the study.
Exclusion Criteria:
- End stage renal disease requiring dialysis.
- Malignant disease.
- On-going infection.
- Diabetes mellitus.
- HIV and/or hepatitis positive.
- Pregnancy.
- Breastfeeding women.
- Participation in other clinical trials within one month before inclusion.
- Abdominal hernia.
- Cardiac diseases other than left ventricular heart failure, biventricular heart failure or isolated right heart chamber failure, with volume overload.
- Any immune deficiency.

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): NCT02772146
Germany | |
Division of Nephrology, Heidelberg University Hospital | |
Heidelberg, Germany, 69120 |
Principal Investigator: | Christian Morath, PD Dr. Med | Division of Nephrology, Heidelberg University Hospital, Germany |
Responsible Party: | Triomed AB |
ClinicalTrials.gov Identifier: | NCT02772146 |
Other Study ID Numbers: |
CIP Version 1D/2015-12-02 CIV-14-07-012440 ( Other Identifier: Eudamed ) Tmed-002 ( Other Identifier: Triomed AB ) |
First Posted: | May 13, 2016 Key Record Dates |
Last Update Posted: | March 14, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | The Sponsor may choose to publish or present data from this clinical investigation. |
Cardio-Renal Syndrome Heart Failure Heart Diseases Cardiovascular Diseases |
Renal Insufficiency Kidney Diseases Urologic Diseases |