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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-14-07-012440 | Other Identifier | Eudamed | |
| Tmed-002 | Other Identifier | Triomed AB |
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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
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: CLS UF | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLS UF | Device | One single ultrafiltration session of 10 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ultrafiltrated volume | Ultrafiltrated volume during a 10 hours study session. | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2-4 weeks | |
| Patient acceptance of the wearable device | Subjective opinion of each patient |
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Inclusion Criteria:
Male or female patient, 18-80 years of age.
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.
Treatment based on night time APD therapy combined with a day time long dwell.
Obtained written consent to participate in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Morath, PD Dr. Med | Division of Nephrology, Heidelberg University Hospital, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nephrology, Heidelberg University Hospital | Heidelberg | Heidelberg | 69120 | Germany |
The Sponsor may choose to publish or present data from this clinical investigation.
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| 10 hours |
| Measured glucose levels in the re-circulated PD fluid | 10 hours |
| Patients acceptability of the re-circulation of PD fluid | Any abdominal symptoms of the drain and fill of PD fluid will be recorded. | 10 hours |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D059347 | Cardio-Renal Syndrome |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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