Post Dialysis Arterio-Venous Fistula Puncture SitesNCT05463315
Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
A study testing Moziak Device in people with Post Dialysis Arterio-Venous Fistula Puncture Sites, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The study aimed to evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Dialysis Arterio-Venous Fistula Puncture Sites
- What is being tested?
- Moziak Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2021to 30 Nov 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing hemodialysis therapy
- Both sex
Who cannot join
- Less than 18 years old
- Patient has central vascular access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed Methods Sequential Explanatory Study to Evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
The study aimed to evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis
Read the detailed description
application of new device to find a Solution for Nursing Challenge for caring patient Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis
- Being tested
- Moziak Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moziak DeviceDevice
Also called Standard Manual Compression
Applying Moziak Device Compared to Standard Manual Compression
| Study group | Role | What they receive |
|---|---|---|
| Moziak Device | Experimental | Applying Moziak Device Compared to Standard Manual Compression Receives: Device: Moziak Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the time of Haemostasis post dialysis
Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start20 Jul 2021
- Primary completion30 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Dialysis Arterio-Venous Fistula Puncture SitesStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Mixed Methods Sequential Explanatory Study
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magda Bayoumi, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463315
- Sponsor's protocol ID
- NURSING119
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 20 Jul 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Sequential Explanatory Study to Evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
- ClinicalTrials.gov ID
- NCT05463315
- Acronym / sponsor ID
- NURSING119
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Jul 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.
The study aimed to evaluate the Effectiveness of Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis
Detailed description
application of new device to find a Solution for Nursing Challenge for caring patient Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Mixed Methods Sequential Explanatory Study
| Arm | Type | Receives |
|---|---|---|
| Moziak Device | Experimental | Device: Moziak DeviceApplying Moziak Device Compared to Standard Manual Compression |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients undergoing hemodialysis therapy
- Both sex
Key exclusion criteria (2 listed)
- Less than 18 years old
- Patient has central vascular access
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 |
|---|---|---|
| Moziak DeviceAlso: Standard Manual CompressionApplying Moziak Device Compared to Standard Manual Compression | Device | Moziak Device |
Primary outcome
Change the time of Haemostasis post dialysis
Time frame: 3 months
Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites
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 20 Jul 2022.
- Individual participant dataSharing planned: No
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?
A study testing Moziak Device in people with Post Dialysis Arterio-Venous Fistula Puncture Sites, run by Beni-Suef University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 20 Jul 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 Egypt. 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?
Change the time of Haemostasis post dialysis (time frame: 3 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 20 Jul 2022.