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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
NA trial testing CLS UF in Heart Failure in 2 participants. Terminated before completion.
23 January 2017
Quick facts
| Lead sponsor | Triomed AB |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 2 |
| Start date | 11 May 2016 |
| Primary completion | 23 January 2017 |
| Estimated completion | 23 January 2017 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- CLS UF
Conditions studied
- Heart Failure — all drugs for Heart Failure →
- Cardio-Renal Syndrome — all drugs for Cardio-Renal Syndrome →
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.
Verify or expand the search:
- PubMed search for NCT02772146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Heart Failure
Currently open trials in the same condition.
- NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
- NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
Other Triomed AB trials
Trials by the same sponsor.
- NCT05874804 — Carry Life@ UF System Clinical Study · NA · completed
- NCT03724682 — A Performance Analysis of the Peritoneal Ultrafiltration (PUF) Achieved With the Carry Life® UF · NA · completed
- NCT03190018 — A Feasibility Study of Peritoneal Dialysis With CLS PD, Which Removes Toxins and Maintains a Stable Ultrafiltration by C · NA · completed
- NCT03128073 — A Feasibility Study of Peritoneal Ultrafiltration With a Wearable Device, CLS UF, That Adds a Glucose-salt Solution to t · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02772146 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Triomed AB
- Last refreshed: 14 March 2017
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