HemodialysisRUF-DNCT06832696
Assessment of a Wearable Ultrafiltration Device
A study testing RUF-D in people with Hemodialysis and Ultrafiltration, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Kidney failure is common. In some people the ability of the kidneys to clean poisons out of the blood gets so low they need to be hooked up to a machine three times a week to do it for them. This is called dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Ultrafiltration
- What is being tested?
- RUF-D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least one of the following:
- Average per-session IDWG ≥ 4.0% of dry weight in the last month
- Inability to consistently achieve dry weight with current HD
- Need for additional HD treatments to achieve prescribed dry weight
- HD sessions three times/week
- Age ≥ 18 years
- Dialyzing via central venous access
- Willing and able to provide informed consent
Who cannot join
- Active infections
- Non-compliance to hemodialysis prescription/schedule
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Initial Assessment of a Wearable Residual Ultrafiltration Device (RUF-D) to Address Challenges Associated With Inadequate Volume Management in Hemodialysis Patients
Kidney failure is common. In some people the ability of the kidneys to clean poisons out of the blood gets so low they need to be hooked up to a machine three times a week to do it for them. This is called dialysis. Unfortunately, although this treatment removes those waste products, people who need dialysis die much more often than people who don't need dialysis. Dialysis causes extreme stress on the body and leads to many organs being damaged.
Removing fluid from the body quickly causes the equivalent of repeated little heart attacks or little strokes in the brain. Many patients struggle to tolerate having all the fluid that they have drunk since their last dialysis session removed- without unpleasant symptoms of dangerously low blood pressure (which makes the damage worse).
Read more
Dialysis treatments can be done more slowly or more often, but that means having to spend a lot more time at the hospital and is difficult for the health system to be able to provide the extra treatment time.
Could extra fluid be removed in between dialysis sessions? Up to now there has not been a way to effectively do this. Investigators have now designed and built an entirely new, very small and very simplified, device that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for conventional dialysis sessions, but it can provide additional and gentle removal of fluid which wasn't able to be taken off during a standard treatment session.
If this study is successful, it will be the first time that a wearable device has been successfully built and used to take off extra fluid when dialysis patients are not in the hospital. The ability to do this opens up the possibility of, 1) helping to treat patients (both making people feel better and live longer) who can't tolerate getting off all the fluid in the short 3-4 hours they are on the dialysis machine in the hospital, and 2) helping patients who feel OK having the fluid taken off but are silently being subjected to damage to their organs due to the rapid removal, have reduced damage.
Read the detailed description
The stress of having rapid removal of fluids and waste products condensed into only a 3-4-hour dialysis treatment results in vital organs being repeatedly starved of blood and injured. Our investigators have been at the forefront of demonstrating that the poor outcomes experienced by patients are a direct result from the HD process itself, and these outcomes can be improved by making changes to the dialysis treatment. Our investigators have led the way in showing that taking off too much fluid faster than the body can tolerate causes damage to multiple organ systems; increasing risk of death and symptoms like breathlessness, intense fatigue, long recovery driving cognitive impairment in the brain, and damaging the liver and kidneys (destroying what is left of their own kidney function much faster). Failure to remove the desired amount of fluid during HD is a common occurrence (often due to patient tolerability of treatment time constraints) and is associated with worse QOL, increased HD-induced ischemic injury (heart, brain etc.). Recurrent cardiac injury and loss of contractile function leads to even poorer tolerability of HD and escalating failure to remove accumulated fluid. Patients in this challenging position typically die within 12 months whilst experiencing increased hospitalizations and adversity.
Even a modest difference in how much fluid needs to be removed is of great clinical significance. For instance, reducing the amount that is removed during a four-hour dialysis treatment by only 1 liter reduces the risk of severe heart injury (which effects the overwhelming majority of people) during that treatment.
Our investigators have completed the essential proof-of-concept phase which has allowed refinement of device design and definition of target focus. The principal focus of this next stage was to build a simplified fluid removal system directed at addressing the challenge of patients being unable to remove all the fluid they need to within the standard dialysis treatment.
The proposed study is a feasibility pilot study of both a novel device and therapeutic approach to volume management. Although significant improvement in volume status would be highly impactful, this study will still be deemed a success if initial experience supports that the use of the device is feasible and useable. Investigators intend to study 18 patients in a prospective unblinded fashion, with all recruited patients utilizing the intervention- allowing comparison of primary and secondary end points from baseline assessment and comparison after successful utilization of RUF-D.
- Conditions
- Hemodialysis, Ultrafiltration
- Being tested
- RUF-D
- Keywords
- Hemodialysis, Ultrafiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUF-DDevice
We have developed a simplified fluid removal device (RUF-D) to address the challenges that patients face with being unable to remove the fluid they need with standard dialysis. Participants 01-09 will receive one week of baseline observation (three HD treatments) with two weeks of supervised intervention using RUF-D post HD on Mondays and Wednesdays for up to six hours (total three-week study).
Participants 10-18 will receive one week of baseline observation, two weeks of intervention (identical to cohort one above), with an additional week of intervention (total four weeks) where participants will be fitted with the RUF-D (ensuring functionality) before going home with the device in operation for up to six hours twice weekly.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving hemodialysis that struggle with fluid removal during dialysis | Experimental | In patients receiving hemodialysis treatment, high amounts of fluid removed in a short time (3-4 hours) can lead to unpleasant symptoms, low blood pressure and can cause bodily stress and organ damage. Leaving this extra fluid in the body also causes undue bodily stress. Investigators need to find gentler, more tolerable ways to remove fluid from patients that need hemodialysis.
Our investigators have designed and built a new, very small and very simplified device (RUF-D) that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for dialysis treatments, but it can provide additional and gentle removal of fluid between dialysis treatments which wasn't able to be taken off during a standard treatment session. Receives: Device: RUF-D |
What is being measured
The primary outcome is the main question the study is designed to answer.
The device is operational
The device turns on and is able to pump blood through the extracorporeal circuit
Measured: From enrollment to end of treatment at 4 weeks.
The device runs for the desired duration
Achieved by a pre-determined amount of fluid to be removed. If the device runs for the desired length of time to achieve the desired amount of ultrafiltration (eg. 500ml at 2ml/min = 4.2hrs)
Measured: From enrollment to end of treatment at 4 weeks.
The device is comfortable to wear
Comfort will be 'measured' by asking for patient input and feedback
Measured: From enrollment to end of treatment at 4 weeks.
Secondary outcomes (3)
Reduction in Hemodialysis induced acute myocardial injury
Reduction in number of regional wall motion abnormalities during HD associated with additional interdialytic ultrafiltration, using the RUF-D assessed by echo at each study visit pre and peak dialysis. Regional left ventricular functional assessment will be performed using 2D echocardiography with commercially available equipment (Vivid-I, GE Healthcare) and subsequent automatic analysis of speckle tracked strain curves using automated software (Echo-Pac GE healthcare). Significant stunning will be defined as 50% reduction in regional longitudinal strain.
Measured: From enrolment until the end of treatment at 4 weeks.
Reduction in Intradialytic Weight Gain
Weight measurements to calculate Intradialytic Weight Gain
Measured: From enrollment to end of study treatment at 4 weeks.
Reduction in Ultrafiltration Requirements during HD
Weight measurements between treatments
Measured: From enrollment to end of treatment at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed study is essentially a feasibility study of both a novel device and therapeutic approach to volume management. Although significant improvement in volume status would be highly impactful, this study will still be deemed a success if initial experience supports that the use of the device is feasible and useable. Efficacy measures relating to the removal of fluid have been chosen to provide objective measures and allow the development of a rational sample size calculation. Investigators aim to study 18 dialysis patients in a prospective unblinded fashion with all recruited participants utilizing the intervention - allowing comparison of primary and secondary end points from baseline assessment and comparison after successful utilization of RUF-D.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Dr. Christopher McIntyre, MBBS DM, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832696
- Sponsor's protocol ID
- 15436
- Acronym
- RUF-D
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Not yet determined
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Assessment of a Wearable Residual Ultrafiltration Device (RUF-D) to Address Challenges Associated With Inadequate Volume Management in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06832696
- Acronym / sponsor ID
- RUF-D / 15436
- Conditions
- Hemodialysis, Ultrafiltration
- Keywords
- Hemodialysis, Ultrafiltration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Feb 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.
Kidney failure is common. In some people the ability of the kidneys to clean poisons out of the blood gets so low they need to be hooked up to a machine three times a week to do it for them. This is called dialysis. Unfortunately, although this treatment removes those waste products, people who need dialysis die much more often than people who don't need dialysis. Dialysis causes extreme stress on the body and leads to many organs being damaged.
Removing fluid from the body quickly causes the equivalent of repeated little heart attacks or little strokes in the brain. Many patients struggle to tolerate having all the fluid that they have drunk since their last dialysis session removed- without unpleasant symptoms of dangerously low blood pressure (which makes the damage worse).
Dialysis treatments can be done more slowly or more often, but that means having to spend a lot more time at the hospital and is difficult for the health system to be able to provide the extra treatment time.
Could extra fluid be removed in between dialysis sessions? Up to now there has not been a way to effectively do this. Investigators have now designed and built an entirely new, very small and very simplified, device that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for conventional dialysis sessions, but it can provide additional and gentle removal of fluid which wasn't able to be taken off during a standard treatment session.
If this study is successful, it will be the first time that a wearable device has been successfully built and used to take off extra fluid when dialysis patients are not in the hospital. The ability to do this opens up the possibility of, 1) helping to treat patients (both making people feel better and live longer) who can't tolerate getting off all the fluid in the short 3-4 hours they are on the dialysis machine in the hospital, and 2) helping patients who feel OK having the fluid taken off but are silently being subjected to damage to their organs due to the rapid removal, have reduced damage.
Detailed description
The stress of having rapid removal of fluids and waste products condensed into only a 3-4-hour dialysis treatment results in vital organs being repeatedly starved of blood and injured. Our investigators have been at the forefront of demonstrating that the poor outcomes experienced by patients are a direct result from the HD process itself, and these outcomes can be improved by making changes to the dialysis treatment. Our investigators have led the way in showing that taking off too much fluid faster than the body can tolerate causes damage to multiple organ systems; increasing risk of death and symptoms like breathlessness, intense fatigue, long recovery driving cognitive impairment in the brain, and damaging the liver and kidneys (destroying what is left of their own kidney function much faster). Failure to remove the desired amount of fluid during HD is a common occurrence (often due to patient tolerability of treatment time constraints) and is associated with worse QOL, increased HD-induced ischemic injury (heart, brain etc.). Recurrent cardiac injury and loss of contractile function leads to even poorer tolerability of HD and escalating failure to remove accumulated fluid. Patients in this challenging position typically die within 12 months whilst experiencing increased hospitalizations and adversity.
Even a modest difference in how much fluid needs to be removed is of great clinical significance. For instance, reducing the amount that is removed during a four-hour dialysis treatment by only 1 liter reduces the risk of severe heart injury (which effects the overwhelming majority of people) during that treatment.
Our investigators have completed the essential proof-of-concept phase which has allowed refinement of device design and definition of target focus. The principal focus of this next stage was to build a simplified fluid removal system directed at addressing the challenge of patients being unable to remove all the fluid they need to within the standard dialysis treatment.
The proposed study is a feasibility pilot study of both a novel device and therapeutic approach to volume management. Although significant improvement in volume status would be highly impactful, this study will still be deemed a success if initial experience supports that the use of the device is feasible and useable. Investigators intend to study 18 patients in a prospective unblinded fashion, with all recruited patients utilizing the intervention- allowing comparison of primary and secondary end points from baseline assessment and comparison after successful utilization of RUF-D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed study is essentially a feasibility study of both a novel device and therapeutic approach to volume management. Although significant improvement in volume status would be highly impactful, this study will still be deemed a success if initial experience supports that the use of the device is feasible and useable. Efficacy measures relating to the removal of fluid have been chosen to provide objective measures and allow the development of a rational sample size calculation. Investigators aim to study 18 dialysis patients in a prospective unblinded fashion with all recruited participants utilizing the intervention - allowing comparison of primary and secondary end points from baseline assessment and comparison after successful utilization of RUF-D.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving hemodialysis that struggle with fluid removal during dialysis | Experimental | Device: RUF-DIn patients receiving hemodialysis treatment, high amounts of fluid removed in a short time (3-4 hours) can lead to unpleasant symptoms, low blood pressure and can cause bodily stress and organ damage. Leaving this extra fluid in the body also causes undue bodily stress. Investigators need to find gentler, more tolerable ways to remove fluid from patients that need hemodialysis. Our investigators have designed and built a new, very small and very simplified device (RUF-D) that can do part of what a dialysis machine does. It doesn't clean the blood or replace the need for dialysis treatments, but it can provide additional and gentle removal of fluid between dialysis treatments which wasn't able to be taken off during a standard treatment session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least one of the following:
- HD sessions three times/week
- Age ≥ 18 years
- Dialyzing via central venous access
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- Active infections
- Non-compliance to hemodialysis prescription/schedule
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 |
|---|---|---|
| RUF-DWe have developed a simplified fluid removal device (RUF-D) to address the challenges that patients face with being unable to remove the fluid they need with standard dialysis. Participants 01-09 will receive one week of baseline observation (three HD treatments) with two weeks of supervised intervention using RUF-D post HD on Mondays and Wednesdays for up to six hours (total three-week study). Participants 10-18 will receive one week of baseline observation, two weeks of intervention (identical to cohort one above), with an additional week of intervention (total four weeks) where participants will be fitted with the RUF-D (ensuring functionality) before going home with the device in operation for up to six hours twice weekly. | Device | Patients receiving hemodialysis that struggle with fluid removal during dialysis |
Primary outcome
The device is operational
Time frame: From enrollment to end of treatment at 4 weeks.
The device turns on and is able to pump blood through the extracorporeal circuit
The device runs for the desired duration
Time frame: From enrollment to end of treatment at 4 weeks.
Achieved by a pre-determined amount of fluid to be removed. If the device runs for the desired length of time to achieve the desired amount of ultrafiltration (eg. 500ml at 2ml/min = 4.2hrs)
The device is comfortable to wear
Time frame: From enrollment to end of treatment at 4 weeks.
Comfort will be 'measured' by asking for patient input and feedback
3 secondary outcomes
Reduction in Hemodialysis induced acute myocardial injury
Time frame: From enrolment until the end of treatment at 4 weeks.
Reduction in Intradialytic Weight Gain
Time frame: From enrollment to end of study treatment at 4 weeks.
Reduction in Ultrafiltration Requirements during HD
Time frame: From enrollment to end of treatment at 4 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. Not yet determined
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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.
Dr. Christopher McIntyre, MBBS DM principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RUF-D in people with Hemodialysis and Ultrafiltration, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 8 inclusion and 2 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: opening soon, as of the sponsor's last update on 29 Apr 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jarrin Penny, RN, PhD, CNeph (C) (519-685-8500 ext. 58765, jarrin.penny@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The device is operational (time frame: From enrollment to end of treatment at 4 weeks.). The study lists 3 primary outcomes in all. 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 29 Apr 2026.