Water QualityHEMOWAQNEWSNCT07247539
Preventing Hemolysis and Reducing Reverse Osmosis Waste With Instantaneous Measurement of Water Quality and Early Warning System in Hemodialysis: A New Method, "Pure Water Eye"
An observational study of Water Quality and Water Consumption, run by Usak State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study validates a novel, continuous, and instantaneous water quality monitoring method, the "Pure Water Eye," for hemodialysis (HD) systems. Current periodic testing leaves patients vulnerable to acute, severe complications like hemolysis due to sudden, undetectable failures in water quality (e.g., chlorine… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Water Quality, Water Consumption, Water-Related Diseases
- What is being tested?
- Pure Water Eye Continuous Monitoring System
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 1 Nov 2025
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Usak Education and Research Hospital Hemodialysis Centre
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak Education and Research Hospital
Uşak, Merkez
About this study
Official title: Diyalizat Saf Su Dijital Takip Sistemi
This study validates a novel, continuous, and instantaneous water quality monitoring method, the "Pure Water Eye," for hemodialysis (HD) systems. Current periodic testing leaves patients vulnerable to acute, severe complications like hemolysis due to sudden, undetectable failures in water quality (e.g., chlorine spikes, pH changes). The "Pure Water Eye" system continuously monitors five key parameters to establish an early warning mechanism, significantly increasing patient safety and allowing for the safe optimization of Reverse Osmosis (RO) water usage, thereby reducing water waste. This system is the first of its kind in Turkey, and globally, it addresses a critical gap where instantaneous and continuous monitoring of HD water quality is not standard practice.
Read the detailed description
The safety of hemodialysis is critically dependent on the quality of the water used, as large volumes directly contact the patient's blood. The current standard of relying on periodic measurements (daily or weekly) fails to detect instantaneous fluctuations in contaminants (e.g., pH, conductivity, chlorine), which can lead to catastrophic events like hemolysis. The "Pure Water Eye" system was developed to perform four measurements per minute across five key parameters: pH, conductivity, chlorine, turbidity, and TDS. This prospective observational study investigated three scenarios: 1) Standard RO measurement, 2) RO waste water reduced by 50%, and 3) RO waste water directly routed back to the raw water tank. The study successfully demonstrated that continuous monitoring is vital for detecting sudden risk moments and is the only safe method for optimizing RO waste reduction without compromising water safety.
- Being tested
- Pure Water Eye Continuous Monitoring System
- Medical subject headings
- Waterborne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure Water Eye Continuous Monitoring SystemDiagnostic test
Pure Water Eye Continuous Monitoring System (Continuous measurement of pH, conductivity, chlorine, turbidity, and TDS)
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of water quality parameters (pH, Chlorine, Conductivity) exceeding safe Hemodialysis guidelines limits as detected by the Pure Water Eye's instantaneous monitoring system, demonstrating the failure rate missed by standard periodic testing.
Measured: through study completion, an average of 3 months
Comparison of water conservation efficiency (reduction in RO waste water volume) between standard RO procedures and the optimized RO waste reduction scenario (Scenario 2: 50% waste reduction) safely managed by instantaneous monitoring.
Measured: through study completion, an average of 3 months
Secondary outcomes (1)
Validation of the correlation between instantaneous conductivity measurements and TDS (Total Dissolved Solids) readings to confirm the accuracy of the new method's core functionality.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Jul 2025
- Primary completion15 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Water QualityStudies 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
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Usak State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ender Hur, Usak State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247539
- Sponsor's protocol ID
- 699-699-03
- Acronym
- HEMOWAQNEWS
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes
Publications
de Oliveira RM, de los Santos CA, Antonello I, d'Avila D. Warning: an anemia outbreak due to chloramine exposure in a clean hemodialysis unit--an issue to be revisited. Ren Fail. 2009;31(1):81-3. doi: 10.1080/08860220802546503.
PubMed 19142815Kasparek T, Rodriguez OE. What Medical Directors Need to Know about Dialysis Facility Water Management. Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1061-71. doi: 10.2215/CJN.11851214. Epub 2015 May 15.
PubMed 25979976Barraclough KA, Moller S, Blair S, Knight R, Agar JW, McAlister S, White A, Sypek M. Updating the Data: The Resource Consumption of Modern-Day Hemodialysis Systems. Kidney Int Rep. 2024 Feb 12;9(5):1521-1524. doi: 10.1016/j.ekir.2024.02.010. eCollection 2024 May. No abstract available.
PubMed 38707837
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diyalizat Saf Su Dijital Takip Sistemi
- ClinicalTrials.gov ID
- NCT07247539
- Acronym / sponsor ID
- HEMOWAQNEWS / 699-699-03
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Usak State HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- 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.
This study validates a novel, continuous, and instantaneous water quality monitoring method, the "Pure Water Eye," for hemodialysis (HD) systems. Current periodic testing leaves patients vulnerable to acute, severe complications like hemolysis due to sudden, undetectable failures in water quality (e.g., chlorine spikes, pH changes). The "Pure Water Eye" system continuously monitors five key parameters to establish an early warning mechanism, significantly increasing patient safety and allowing for the safe optimization of Reverse Osmosis (RO) water usage, thereby reducing water waste. This system is the first of its kind in Turkey, and globally, it addresses a critical gap where instantaneous and continuous monitoring of HD water quality is not standard practice.
Detailed description
The safety of hemodialysis is critically dependent on the quality of the water used, as large volumes directly contact the patient's blood. The current standard of relying on periodic measurements (daily or weekly) fails to detect instantaneous fluctuations in contaminants (e.g., pH, conductivity, chlorine), which can lead to catastrophic events like hemolysis. The "Pure Water Eye" system was developed to perform four measurements per minute across five key parameters: pH, conductivity, chlorine, turbidity, and TDS. This prospective observational study investigated three scenarios: 1) Standard RO measurement, 2) RO waste water reduced by 50%, and 3) RO waste water directly routed back to the raw water tank. The study successfully demonstrated that continuous monitoring is vital for detecting sudden risk moments and is the only safe method for optimizing RO waste reduction without compromising water safety.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Usak Education and Research Hospital Hemodialysis Centre
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Pure Water Eye Continuous Monitoring SystemPure Water Eye Continuous Monitoring System (Continuous measurement of pH, conductivity, chlorine, turbidity, and TDS) | Diagnostic test | – |
Primary outcome
Incidence of water quality parameters (pH, Chlorine, Conductivity) exceeding safe Hemodialysis guidelines limits as detected by the Pure Water Eye's instantaneous monitoring system, demonstrating the failure rate missed by standard periodic testing.
Time frame: through study completion, an average of 3 months
Comparison of water conservation efficiency (reduction in RO waste water volume) between standard RO procedures and the optimized RO waste reduction scenario (Scenario 2: 50% waste reduction) safely managed by instantaneous monitoring.
Time frame: through study completion, an average of 3 months
1 secondary outcome
Validation of the correlation between instantaneous conductivity measurements and TDS (Total Dissolved Solids) readings to confirm the accuracy of the new method's core functionality.
Time frame: through study completion, an average of 3 months
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 25 Nov 2025.
- Results publication: PubMed 19142815de Oliveira RM, de los Santos CA, Antonello I, d'Avila D. Warning: an anemia outbreak due to chloramine exposure in a clean hemodialysis unit--an issue to be revisited. Ren Fail. 2009;31(1):81-3. doi: 10.1080/08860220802546503.
- Results publication: PubMed 25979976Kasparek T, Rodriguez OE. What Medical Directors Need to Know about Dialysis Facility Water Management. Clin J Am Soc Nephrol. 2015 Jun 5;10(6):1061-71. doi: 10.2215/CJN.11851214. Epub 2015 May 15.
- Results publication: PubMed 38707837Barraclough KA, Moller S, Blair S, Knight R, Agar JW, McAlister S, White A, Sypek M. Updating the Data: The Resource Consumption of Modern-Day Hemodialysis Systems. Kidney Int Rep. 2024 Feb 12;9(5):1521-1524. doi: 10.1016/j.ekir.2024.02.010. eCollection 2024 May. No abstract available.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Water Quality and Water Consumption, run by Usak State Hospital at 1 site in Turkey (Türkiye).
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 0 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 25 Nov 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 Turkey (Türkiye). 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?
Incidence of water quality parameters (pH, Chlorine, Conductivity) exceeding safe Hemodialysis guidelines limits as detected by the Pure Water Eye's instantaneous monitoring system, demonstrating the failure rate missed by standard periodic testing. (time frame: through study completion, an average of 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07247539, which also lists 3 linked publications.
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 25 Nov 2025.