Trials / Completed
CompletedNCT02292212
Clinical Study of Asahi ViE Dialyzer in Canada
Clinical Study of Asahi ViE Dialyzer in Canada (AVID)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Asahi Kasei Medical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to obtain performance data on the Asahi ViE-21 dialyzer (ViE-21) .
Detailed description
The objective of the study is to evaluate specific parameters related to ViE-21 performance including (A) Performance evaluated by uremic solute removal rates of urea, creatinine, albumin and B2-MG, (B) Determination of KUF, (C) Biocompatibility evaluated by WBC, platelet and C3a measurements, (D) Type and number of adverse events, (E) Type and number of device malfunctions. Prospective, open-label, non-randomized, single-armed, controlled study. Each patient shall have data collected for six dialysis sessions each on a control dialyzer prior to and after 36 sessions with the ViE-21. These data shall be the basis of comparison for the ViE-21 performance. These data will be utilized in support of a US Regulatory Submission.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ViE-21 | The subjects will be undergone three times KUF measurement sessions and three times blood sampling sessions during study period. |
Timeline
- Start date
- 2014-11-24
- Primary completion
- 2015-11-06
- Completion
- 2015-11-06
- First posted
- 2014-11-17
- Last updated
- 2019-12-11
- Results posted
- 2017-08-17
Source: ClinicalTrials.gov record NCT02292212. Inclusion in this directory is not an endorsement.