HemodialysisNCT00579202
Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
An observational study of Hemodialysis, run by Vantive Health LLC at 1 site in United States.
Trial summary
The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Gambro HD-C4 Small Dialyzer
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy of adult (≥ 18 years of age) patients
Who may be able to join
- n/a routine dialysis patients
Who cannot join
- n/a routine dialysis patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Gambro Polyflux HD-C4 Small Ease of Use Study
The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis
Read the detailed description
Market evaluation protocol.
This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy.
- Conditions
- Hemodialysis
- Being tested
- Gambro HD-C4 Small Dialyzer
- Keywords
- Dialyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gambro HD-C4 Small DialyzerDevice
Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
For each dialyzer, the perceived ease of priming.
Measured: During priming of each dialyzer
Secondary outcomes (1)
Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.
Measured: At the completion of each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Renal Products, Inc., Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Rana Irmindra, M.D., Principal investigator, Advanced Dialysis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579202
- Sponsor's protocol ID
- 07-0002
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2007
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gambro Polyflux HD-C4 Small Ease of Use Study
- ClinicalTrials.gov ID
- NCT00579202
- Acronym / sponsor ID
- 07-0002
- Conditions
- Hemodialysis
- Keywords
- Dialyzer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Renal Products, Inc., Baxter Healthcare Corporation
- Study start
- Oct 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis
Detailed description
Market evaluation protocol.
This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy of adult (≥ 18 years of age) patients
Key inclusion criteria (1 listed)
- n/a routine dialysis patients
Key exclusion criteria (1 listed)
- n/a routine dialysis patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gambro HD-C4 Small DialyzerInvolves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. | Device | – |
Primary outcome
For each dialyzer, the perceived ease of priming.
Time frame: During priming of each dialyzer
1 secondary outcome
Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.
Time frame: At the completion of each treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana Irmindra, M.D. principal investigator
Advanced Dialysis Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis, run by Vantive Health LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For each dialyzer, the perceived ease of priming. (time frame: During priming of each dialyzer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.