End Stage Renal DiseaseACTNCT05285436
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis
A study testing CloudCath System in people with End Stage Renal Disease and Peritoneal Dialysis-associated Peritonitis, run by CloudCath at 1 site in United States.
Trial summary
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Peritoneal Dialysis-associated Peritonitis, Peritonitis
- What is being tested?
- CloudCath System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2022to Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- currently using peritoneal dialysis
- provides informed consent
- willing to comply with the requirements of the study
- has cellular data coverage at home
Who cannot join
- active or history of cancer requiring chemotherapy within prior 6 months
- signs or symptoms of an active infection within 14 days prior to enrollment
- peritonitis diagnosis within 30 days prior to enrollment
- participating in another investigational device or drug study that may potentially affect study results
- other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study
Trial locations and contacts
1 site in 1 country.
Concetta Carbonaro contact
United States1 site, 1 recruiting
- Recruiting
Dialysis Center of Western Massachusetts Llc
Chicopee, Massachusetts, 01020
Concetta Carbonaro
About this study
Official title: A Prospective Clinical Study to Assess the Clinical Utility of Turbidity With the CloudCath System in Patients Using In-Home Peritoneal Dialysis
This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
Read the detailed description
This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care.
Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider.
Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.
Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.
- Being tested
- CloudCath System
- Medical subject headings
- Kidney Failure, Chronic, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CloudCath SystemDevice
The CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent.
| Study group | Role | What they receive |
|---|---|---|
| CloudCath detection | Experimental | Active monitoring of dialysate effluent by the CloudCath System. Receives: Device: CloudCath System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to peritonitis diagnosis
The time between detection by the CloudCath System and laboratory confirmation of peritonitis.
Measured: 12-months
Secondary outcomes (4)
Agreement in peritonitis detection between the CloudCath System and clinical criteria.
clinical criteria include: white blood cells (WBC) (>100 cells per microliter or >0.1 x10^9/L), polymorphonuclear cells (PMN) (>50%), microbiology culture results, gram staining, and peritonitis symptoms
Measured: 12-months
Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis
Clinically actionable events defined as an event which requires treatment (i.e., prescribing medications, cleaning an exit site, etc) or intervention (i.e., PD catheter manipulation, removal).
Events of interest for this protocol include, but are not limited to, peritonitis, exit site or tunnel infection, and peritoneal dialysis (PD) catheter dysfunction (including PD catheter-related bleeding and PD catheter-related drainage issues).
Measured: 12-months
Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.
Clinically relevant events are defined as clinically actionable events, events treated preventatively or medically relevant events.
Measured: 12-months
Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing
Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start16 Mar 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All study participants receive a CloudCath Device and use it at home adjunctively to their regular peritoneal dialysis system.
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CloudCath
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Chertow, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285436
- Sponsor's protocol ID
- CC-P-002
- Acronym
- ACT
- Status last verified
- Sep 2023
- First submitted
- 9 Mar 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study to Assess the Clinical Utility of Turbidity With the CloudCath System in Patients Using In-Home Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT05285436
- Acronym / sponsor ID
- ACT / CC-P-002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 314 participants (estimated)
- Lead sponsor
- CloudCathIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Mar 2022 (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 aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.
Detailed description
This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care.
Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The system will alert the participant and healthcare provider if it detects a possible infection so they can be formally diagnosed by their healthcare provider.
Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.
Study results from the ACT study will be compared to the results of the CATCH Study (Protocol number CC-P-001; NCT04515498). In CATCH, the Study Participants used a CloudCath System; however, the notification capabilities (per the CloudCath System algorithm) were deactivated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All study participants receive a CloudCath Device and use it at home adjunctively to their regular peritoneal dialysis system.
| Arm | Type | Receives |
|---|---|---|
| CloudCath detection | Experimental | Device: CloudCath SystemActive monitoring of dialysate effluent by the CloudCath System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- currently using peritoneal dialysis
- provides informed consent
- willing to comply with the requirements of the study
- has cellular data coverage at home
Key exclusion criteria (5 listed)
- active or history of cancer requiring chemotherapy within prior 6 months
- signs or symptoms of an active infection within 14 days prior to enrollment
- peritonitis diagnosis within 30 days prior to enrollment
- participating in another investigational device or drug study that may potentially affect study results
- other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study
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 |
|---|---|---|
| CloudCath SystemThe CloudCath System enables drainage and measures turbidity, reported as a numeric score, in peritoneal dialysate effluent. | Device | CloudCath detection |
Primary outcome
Time to peritonitis diagnosis
Time frame: 12-months
The time between detection by the CloudCath System and laboratory confirmation of peritonitis.
4 secondary outcomes
Agreement in peritonitis detection between the CloudCath System and clinical criteria.
Time frame: 12-months
Agreement in detection of clinically actionable events between the CloudCath System and laboratory reports and/or diagnosis
Time frame: 12-months
Agreement in detection of clinically relevant events based on CloudCath System, as compared to clinical laboratory results or diagnosis of a clinically relevant event.
Time frame: 12-months
Sensitivity and Specificity of the CloudCath System to detect peritonitis as compared to diagnostic laboratory testing
Time frame: 12-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Concetta Carbonaro contact
Glenn Chertow, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CloudCath System in people with End Stage Renal Disease and Peritoneal Dialysis-associated Peritonitis, run by CloudCath 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Fisher (+1 (415) 651-3393, brian@cloudcath.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to peritonitis diagnosis (time frame: 12-months). 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 21 Sep 2023.