End Stage Renal Failure on DialysisNCT03645720
The Prognosis of Graft Using Plastic Cannula in Hemodialysis
A study testing Plastic cannula in people with End Stage Renal Failure on Dialysis, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the complication of the puncture related complication in AVG (arteriovenous graft) such as pseudoaneurysm and hematoma, and the dialysis adequacy using plastic cannula versus metal needle in hemodialysis patients Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- Plastic cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2018to Jun 2019
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving hemodialysis treatment using AVG
Who cannot join
- Age under 20 years old or over 75 years old
- Abnormal skin condition using immunosuppressants such as steroids.
- Skin disorder
- Metal allergy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14066
About this study
Official title: A Prospective Study of the Prognosis of Graft With Plastic Cannula in Hemodialysis
The purpose of this study is to evaluate the complication of the puncture related complication in AVG (arteriovenous graft) such as pseudoaneurysm and hematoma, and the dialysis adequacy using plastic cannula versus metal needle in hemodialysis patients
Read the detailed description
- Ultrasonography is performed to determine the maturity of vascular access 4 weeks after AVG creation.
- The first puncture is performed with plastic cannula or metal needle when it is judged that the blood vessel has matured.
- Four skilled nurses perform vascular access puncture with plastic or metal needle
- Ultrasound are used to evaluate and record the complications related to the puncture in plastic or metal needle group every month.
- Complications and dialysis adequacy between the two groups will be evaluated after 6 months
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- Plastic cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plastic cannulaDevice
puncture using plastic cannula
| Study group | Role | What they receive |
|---|---|---|
| Metal needle gruop | No intervention | puncture using metal needle |
| plastic cannula | Experimental | puncture using plastic cannula Receives: Device: Plastic cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pseudoaneurysm
critical puncture related complication in AVG
Measured: Incidence of pseudoaneurysm at 6 months
Secondary outcomes (2)
punctutre related complication
hematoma, inflitration, thrombus
Measured: Monthly for 6 months.
Dialysis adeqaucy
Kt/V by serum test in two groups
Measured: Monthly for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start22 Oct 2018
- Primary completionMay 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: difficulty in performing study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, choi sun ryoung, MD, Hallym University Medical Center
- Investigators
- Sun Ryoung Choi, MD,PhD, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645720
- Sponsor's protocol ID
- 2018-05-030
- Status last verified
- Aug 2022
- First submitted
- 21 Aug 2018
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Prognosis of Graft With Plastic Cannula in Hemodialysis
- ClinicalTrials.gov ID
- NCT03645720
- Acronym / sponsor ID
- 2018-05-030
- Conditions
- End Stage Renal Failure on Dialysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulty in performing study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 24 Aug 2018 (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 purpose of this study is to evaluate the complication of the puncture related complication in AVG (arteriovenous graft) such as pseudoaneurysm and hematoma, and the dialysis adequacy using plastic cannula versus metal needle in hemodialysis patients
Detailed description
- Ultrasonography is performed to determine the maturity of vascular access 4 weeks after AVG creation.
- The first puncture is performed with plastic cannula or metal needle when it is judged that the blood vessel has matured.
- Four skilled nurses perform vascular access puncture with plastic or metal needle
- Ultrasound are used to evaluate and record the complications related to the puncture in plastic or metal needle group every month.
- Complications and dialysis adequacy between the two groups will be evaluated after 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Metal needle gruop | No intervention | –puncture using metal needle |
| plastic cannula | Experimental | Device: Plastic cannulapuncture using plastic cannula |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving hemodialysis treatment using AVG
Key exclusion criteria (4 listed)
- Age under 20 years old or over 75 years old
- Abnormal skin condition using immunosuppressants such as steroids.
- Skin disorder
- Metal allergy
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 |
|---|---|---|
| Plastic cannulapuncture using plastic cannula | Device | plastic cannula |
Primary outcome
Incidence of pseudoaneurysm
Time frame: Incidence of pseudoaneurysm at 6 months
critical puncture related complication in AVG
2 secondary outcomes
punctutre related complication
Time frame: Monthly for 6 months.
Dialysis adeqaucy
Time frame: Monthly for 6 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- 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.
Sun Ryoung Choi, MD,PhD principal investigator
Hallym University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plastic cannula in people with End Stage Renal Failure on Dialysis, run by Hallym University Medical Center at 1 site in South Korea.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 3 Aug 2022. 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 South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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 pseudoaneurysm (time frame: Incidence of pseudoaneurysm at 6 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 3 Aug 2022.