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

16 May 2008

The date of last modification

Mar 03, 2019


Trial Status



Application Summary


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)


Trial Details


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

  1. Candidates for implantattion of a prosthetic vascular access graft for haemodialysis access.these are patients who are not eligible for creation of native fistulae according to the standard of care in the medical center 2. Male or female subjects 18 year or older of any race 3. Subjects willing to participate as evidenced by signing the written informed consent

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

[]

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



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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