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This study is designed to monitor and assess the safety of continued access to the HemoCareâ„¢ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCareâ„¢ Hemodialysis System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The HemoCareâ„¢ Hemodialysis System | Experimental | The HemoCareâ„¢ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCareâ„¢ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HemoCareâ„¢ Hemodialysis System | Device | The HemoCareâ„¢ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCareâ„¢ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Safety Event | The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs. | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39213 | United States | ||
| DCI North Brunswick |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18160958 | Background | Eloot S, Van Biesen W, Dhondt A, Van de Wynkele H, Glorieux G, Verdonck P, Vanholder R. Impact of hemodialysis duration on the removal of uremic retention solutes. Kidney Int. 2008 Mar;73(6):765-70. doi: 10.1038/sj.ki.5002750. Epub 2007 Dec 26. | |
| 17878421 | Background | Culleton BF, Walsh M, Klarenbach SW, Mortis G, Scott-Douglas N, Quinn RR, Tonelli M, Donnelly S, Friedrich MG, Kumar A, Mahallati H, Hemmelgarn BR, Manns BJ. Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial. JAMA. 2007 Sep 19;298(11):1291-9. doi: 10.1001/jama.298.11.1291. |
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| ID | Title | Description |
|---|---|---|
| FG000 | The HemoCareâ„¢ Hemodialysis System | All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | The HemoCareâ„¢ Hemodialysis System | All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Safety Event | The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs. | Posted | Number | participants | 52 weeks |
|
|
During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The HemoCareâ„¢ Hemodialysis System | All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest discomfort | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Regulatory Affairs Manager | DEKA Research | 603-669-6491 | psmolenski@dekaresearch.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2022 | Aug 18, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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This is an open-label rollover study.
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|
| North Brunswick |
| New Jersey |
| 08902 |
| United States |
| The Rogosin Institute | New York | New York | 11021 | United States |
| Dialysis Clinic, Inc. | Knoxville | Tennessee | 37920 | United States |
| Dialysis Clinic, Inc. | Nashville | Tennessee | 37203 | United States |
| Wellbound South Austin | Austin | Texas | 78744 | United States |
| Wellbound North Austin | Austin | Texas | 78758 | United States |
| 21775973 | Background | Rocco MV, Lockridge RS Jr, Beck GJ, Eggers PW, Gassman JJ, Greene T, Larive B, Chan CT, Chertow GM, Copland M, Hoy CD, Lindsay RM, Levin NW, Ornt DB, Pierratos A, Pipkin MF, Rajagopalan S, Stokes JB, Unruh ML, Star RA, Kliger AS; Frequent Hemodialysis Network (FHN) Trial Group; Kliger A, Eggers P, Briggs J, Hostetter T, Narva A, Star R, Augustine B, Mohr P, Beck G, Fu Z, Gassman J, Greene T, Daugirdas J, Hunsicker L, Larive B, Li M, Mackrell J, Wiggins K, Sherer S, Weiss B, Rajagopalan S, Sanz J, Dellagrottaglie S, Kariisa M, Tran T, West J, Unruh M, Keene R, Schlarb J, Chan C, McGrath-Chong M, Frome R, Higgins H, Ke S, Mandaci O, Owens C, Snell C, Eknoyan G, Appel L, Cheung A, Derse A, Kramer C, Geller N, Grimm R, Henderson L, Prichard S, Roecker E, Rocco M, Miller B, Riley J, Schuessler R, Lockridge R, Pipkin M, Peterson C, Hoy C, Fensterer A, Steigerwald D, Stokes J, Somers D, Hilkin A, Lilli K, Wallace W, Franzwa B, Waterman E, Chan C, McGrath-Chong M, Copland M, Levin A, Sioson L, Cabezon E, Kwan S, Roger D, Lindsay R, Suri R, Champagne J, Bullas R, Garg A, Mazzorato A, Spanner E, Rocco M, Burkart J, Moossavi S, Mauck V, Kaufman T, Pierratos A, Chan W, Regozo K, Kwok S. The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial. Kidney Int. 2011 Nov;80(10):1080-91. doi: 10.1038/ki.2011.213. Epub 2011 Jul 20. |
| 19584107 | Background | Pauly RP, Gill JS, Rose CL, Asad RA, Chery A, Pierratos A, Chan CT. Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients. Nephrol Dial Transplant. 2009 Sep;24(9):2915-9. doi: 10.1093/ndt/gfp295. Epub 2009 Jul 7. |
| 27190336 | Background | Bernardo AA, Marbury TC, McFarlane PA, Pauly RP, Amdahl M, Demers J, Hutchcraft AM, Leypoldt JK, Minkus M, Muller M, Stallard R, Culleton BF. Clinical safety and performance of VIVIA: a novel home hemodialysis system. Nephrol Dial Transplant. 2017 Apr 1;32(4):685-692. doi: 10.1093/ndt/gfw044. |
| Background | U.S. Renal Data System. USRDS 2017 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2017 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
|
| 1 |
| 25 |
| 15 |
| 25 |
| 22 |
| 25 |
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hyperparathyroidism | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arteriovenous fistula site infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Respiratory syncytial virus infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arteriovenous fistula aneurysm | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vascular access site thrombosis | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypervolemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bell's palsy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Renal transplant | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Localized infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Post procedural hemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vascular access site hemorrhage | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood phosphorus increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hemoglobin decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Heart rate increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Hypoesthesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Thrombosis in device | Product Issues | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hemorrhage | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |