Back to resultsApplying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
Primary Purpose
Post Dialysis Arterio-Venous Fistula Puncture Sites
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Moziak Device
Sponsored by
About this trial
This is an interventional supportive care trial for Post Dialysis Arterio-Venous Fistula Puncture Sites
Eligibility Criteria
Inclusion Criteria:
- All patients undergoing hemodialysis therapy
- Both sex
Exclusion Criteria:
- Less than 18 years old
- Patient has central vascular access
Sites / Locations
- Mansoura University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Moziak Device
Arm Description
Applying Moziak Device Compared to Standard Manual Compression
Outcomes
Primary Outcome Measures
Change the time of Haemostasis post dialysis
Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05463315
Brief Title
Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed Description
application of new device to find a Solution for Nursing Challenge for caring patient Post Dialysis Arterio-Venous Fistula Puncture Sites Haemostasis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Dialysis Arterio-Venous Fistula Puncture Sites
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A Mixed Methods Sequential Explanatory Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moziak Device
Arm Type
Experimental
Arm Description
Applying Moziak Device Compared to Standard Manual Compression
Intervention Type
Device
Intervention Name(s)
Moziak Device
Other Intervention Name(s)
Standard Manual Compression
Intervention Description
Applying Moziak Device Compared to Standard Manual Compression
Primary Outcome Measure Information:
Title
Change the time of Haemostasis post dialysis
Description
Applying Moziak Device Compared to Standard Manual Compression Post Dialysis Arterio-Venous Fistula Puncture Sites
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients undergoing hemodialysis therapy
Both sex
Exclusion Criteria:
Less than 18 years old
Patient has central vascular access
Facility Information:
Facility Name
Mansoura University Hospital
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Applying Moziak Device Compared to Standard Manual Compression on Arterio-Venous Fistula Puncture Sites Haemostasis
We'll reach out to this number within 24 hrs