ESRD (End Stage Renal Disease)NCT07217041
Fluid Status of Dialysis Subjects
An observational study of ESRD (End Stage Renal Disease), run by HemoCept Inc. at 1 site in United States.
Trial summary
The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data during dialysis and HemoCept device data. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESRD (End Stage Renal Disease)
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 9 Jun 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects between (and including) the ages of 18 and 75 and who meet all the Inclusion/Exclusion criteria
Who may be able to join
- Study or representatives must have voluntarily signed the informed consent form before any study related procedures
- Subjects can be any gender, but must be between (and including) 18 and 75 years of age
- Subject has been on dialysis for more than 90 days and has been diagnosed with end stage kidney disease
- Subject is willing and able to provide informed consent and HIPAA authorization • Subject is able and willing to meet all study requirements
- Subject is able to place electrodes on bilateral deltoids and above the pant line on the waist
Who cannot join
- Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
- Subject has a personal medical history that includes:
- Long Q-T syndrome
- Cardiac channelopathies, genetic heart defects
- Seizures
- Acute untreated blood clotting disorders or acute untreated bleeding disorders
- Subject has had a heart transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Clinical Study to Assess the Correlation Between Fluid Removal During Dialysis and HemoCept Device Data
The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data during dialysis and HemoCept device data.
- Conditions
- ESRD (End Stage Renal Disease)
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between HemoCept device and changes in dry weight.
The primary end point will be to determine if there is a correlation between HemoCept device data and dry weight changes during dialysis. The primary analysis will be conducted at specific points during dialysis treatment: prior to dialysis, in the middle of the dialysis session, and immediately following the completion of dialysis treatment.
Measured: At specified points during dialysis treatment for 9 dialysis sessions, over the course of 3 weeks.
Secondary outcomes (1)
Device-related adverse events: device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure
All secondary endpoints will be summarized descriptively, and no hypothesis tests are planned.
Measured: From enrollment until the completion of 9 dialysis sessions, over a period of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start19 Mar 2025
- Primary completion12 May 2025
- Study completion9 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRD (End Stage Renal Disease)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- HemoCept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217041
- Sponsor's protocol ID
- PRT-010
- Status last verified
- Oct 2025
- First submitted
- 16 Sep 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study to Assess the Correlation Between Fluid Removal During Dialysis and HemoCept Device Data
- ClinicalTrials.gov ID
- NCT07217041
- Acronym / sponsor ID
- PRT-010
- Conditions
- ESRD (End Stage Renal Disease)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- HemoCept Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 15 Oct 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.
The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data during dialysis and HemoCept device data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects between (and including) the ages of 18 and 75 and who meet all the Inclusion/Exclusion criteria
Key inclusion criteria (5 listed)
- Study or representatives must have voluntarily signed the informed consent form before any study related procedures
- Subjects can be any gender, but must be between (and including) 18 and 75 years of age
- Subject has been on dialysis for more than 90 days and has been diagnosed with end stage kidney disease
- Subject is willing and able to provide informed consent and HIPAA authorization • Subject is able and willing to meet all study requirements
- Subject is able to place electrodes on bilateral deltoids and above the pant line on the waist
Key exclusion criteria (7 listed)
- Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
- Subject has a personal medical history that includes:
- Subject has had a heart transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between HemoCept device and changes in dry weight.
Time frame: At specified points during dialysis treatment for 9 dialysis sessions, over the course of 3 weeks.
The primary end point will be to determine if there is a correlation between HemoCept device data and dry weight changes during dialysis. The primary analysis will be conducted at specific points during dialysis treatment: prior to dialysis, in the middle of the dialysis session, and immediately following the completion of dialysis treatment.
1 secondary outcome
Device-related adverse events: device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure
Time frame: From enrollment until the completion of 9 dialysis sessions, over a period of 3 weeks.
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 15 Oct 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
Related trials for ESRD (End Stage Renal Disease)
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
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 ESRD (End Stage Renal Disease), run by HemoCept Inc. 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 5 inclusion and 7 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 15 Oct 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?
Correlation between HemoCept device and changes in dry weight. (time frame: At specified points during dialysis treatment for 9 dialysis sessions, over the course of 3 weeks.). 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 15 Oct 2025.