Peritoneal Dialysis-associated PeritonitisCATCHNCT04515498
A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis
An observational study of 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
- Peritoneal Dialysis-associated Peritonitis
- What is being tested?
- CloudCath Monitoring System
- Type of treatment
- Medical device
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2020to 31 Mar 2023
- 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: Patients currently using home peritoneal dialysis.
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.
United States1 site
CloudCath Investigational Site
Lakewood, Colorado, 80226
About this study
Official title: A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During 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 notification capability of the CloudCath System will be deactivated for this study so that neither Study Participants nor Study Investigators will be aware of the device measurements.
Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.
- Being tested
- CloudCath Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CloudCath Monitoring SystemDevice
The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.
| Study group | Role | What they receive |
|---|---|---|
| CloudCath System | Patients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis Receives: Device: CloudCath Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of peritonitis detection (vs lab measures)
The time peritonitis is detected by the CloudCath System, as compared to time of laboratory evidence of peritonitis
Measured: through 12 months
Secondary outcomes (3)
Time of peritonitis detection (vs clinical measures)
The time peritonitis is detected by the CloudCath System, as compared to time of peritonitis detection by standard clinical means (ISPD guidelines)
Measured: through 12 months
Sensitivity and specificity of the CloudCath System detection of peritonitis
Analysis of sensitivity and specificity of CloudCath System detection of peritonitis, as compared to diagnostic laboratory testing
Measured: through 12 months
Ability of study participants to use the CloudCath System as intended
Device performance measure; ability to use as intended
Measured: through 12-months of study follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start19 Aug 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis-associated PeritonitisStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 243 participants (actual)
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
- NCT04515498
- Sponsor's protocol ID
- CC-P-001
- Acronym
- CATCH
- Status last verified
- May 2023
- First submitted
- 13 Aug 2020
- Last updated
- 30 May 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of the Ability of the CloudCath System to Detect Peritonitis During In-home Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT04515498
- Acronym / sponsor ID
- CATCH / CC-P-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- CloudCathIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 17 Aug 2020 (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 notification capability of the CloudCath System will be deactivated for this study so that neither Study Participants nor Study Investigators will be aware of the device measurements.
Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CloudCath System | – | Device: CloudCath Monitoring SystemPatients with End Stage Renal Disease (ESRD) currently using home peritoneal dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients currently using home peritoneal dialysis.
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 Monitoring SystemThe CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis. | Device | CloudCath System |
Primary outcome
Time of peritonitis detection (vs lab measures)
Time frame: through 12 months
The time peritonitis is detected by the CloudCath System, as compared to time of laboratory evidence of peritonitis
3 secondary outcomes
Time of peritonitis detection (vs clinical measures)
Time frame: through 12 months
Sensitivity and specificity of the CloudCath System detection of peritonitis
Time frame: through 12 months
Ability of study participants to use the CloudCath System as intended
Time frame: through 12-months of study follow-up
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 30 May 2023.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis-associated Peritonitis
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RecruitingPhase 4
Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis
Peritoneal Dialysis-associated Peritonitis
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.
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?
An observational study of 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: finished, as of the sponsor's last update on 30 May 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?
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?
Time of peritonitis detection (vs lab measures) (time frame: through 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 30 May 2023.