Home » Trials » SLCTR/2008/009
A prospective open label randomized clinical study to evaluate the safety and effectiveness of the NICAST polyurethane vascular access graft
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SLCTR Registration Number
SLCTR/2008/009
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A prospective open label randomized clinical study to evaluate the safety and effectiveness of the NICAST polyurethane vascular access graft
Public Title of Trial
A study to evaluate the safety and effectiveness of the NICAST Polyurethane vascular access graft
Disease or Health Condition(s) Studied
Using NICAST polyurethane graft for vascular access for haemodialysis in chronic renal failure patients.
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/07/006 (Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Using NICAST polyurethane graft for vascular access in haemodialysis. evaluating the ability of early access and ability to withstand multiple punctures are being addressed. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Other
Study Phase
Not Available
Intervention(s) planned
Use NICAST graft as a arteriovenous conduit for vascular access in haemodialysis in chronic renal failure patients
Inclusion criteria
Exclusion criteria
Subjects with any medical condition that would expose the subject to increased risk by the investigational device or procedure according to the investigator's decision Subjects with elevated WBC counts Subjects with bilirubin level >3mg/dl Concurrent existence of another vascular access graft in the same limb Subjects with known hypersensitivity or allergy to polyurethane products or any other contraindication to implantation of a polyurethane graft Female subjects who are pregnant or lactating Subjects participating in any other clinical study at the same time
Primary outcome(s)
1.
•Primary patency •Incidence of thrombosis •18 month functional patency rates •Overall incidence of intraoperative and postoperative complications |
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Secondary outcome(s)
1.
-Time to first puncture of the graft -Frequency of temporary catheter use prior to first puncture -Difficulty of graft puncture -Haemostasis time |
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Target number/sample size
30
Countries of recruitment
Sri Lanka
Anticipated start date
2007-07-07
Anticipated end date
2009-07-01
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
NICAST Ltd. Global Park, 2 Yodfat Street, Nothern Industrial Zone, Lod 71291, Israel
Regulatory approvals
Status
Approved
Date of Approval
2007-03-29
Approval number
EC/07/006
Details of Ethics Review Committee
Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
Telephone: | +94-11-2695300 (Extension: 240) |
Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Mandika Wijeyaratne
Head, Department of Surgery,
Faculty of Medicine, Colombo
0777344482
mandika59@hotmail.com
Contact Person for Public Queries
Mandika Wijeyaratne
Head, Department of Surgery,
Faculty of Medicine, Colombo
0777344482
mandika59@hotmail.com
Primary study sponsor/organization
Nicast Ltd
Global Park, 2 Yodfat Street,
Northern Industrial Zone, Lod 71291, Israel.
+97289153001
+97289153002
http://www.nicast.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results