Prospective multi-centre observational pilot study to investigate the safety and efficacy of the Venous Window Needle GuideTM (VWNG) (SAVE-2 study)

Not Applicable

Completed

• Conditions: Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders; Urological and Genital Diseases

• Registration Number: ISRCTN79284836
• Lead Sponsor: Central Manchester University Hospitals NHS Trust (CMFT) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-29
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. The participant has an un-cannulatable (per the provided definition) upper arm or forearm cephalic, basilic or brachial vein outflow arteriovenous (AV) fistula AND/OR the subjects and their clinicians opt for self-cannulation
2. The participant has received or is in imminent need of receiving haemodialysis treatment and will receive in-center or home haemodialysis treatments at least two times per week
3. Subject?s fistula diameter is at least 5 mm at the planned site of device attachment
4. Buttonhole cannulation technique is appropriate for the subject
5. Subject?s fistula does not have clinically significant flow abnormalities and has adequate fistula flow (=400 ml/min) to achieve optimum dialysis or dialysis as prescribed
6. The AV fistula is in the range of 4 to 15 mm in depth at the anticipated VWNG access site(s)
7. Subject?s life expectancy is at least 1 year, based on clinician?s assessment of medical condition
8. The participant has understood the Informed Consent and has agreed to participate in the study
9. Target Gender: Male & Female ; Lower Age Limit 18 years

Exclusion Criteria

1. Subject has recent (within past month) occurrence and/or intervention for AV access stenosis or thrombosis
2. Subject has AV fistula that has undergone a major revision such as AVF resection with PTFE graft insertion, vascular stent placement at cannulation site, complete ligation or closure, requires construction of new anastomosis, a flow-limiting procedure including a DRIL or banding procedure or surgical intervention for an aneurysm at the implant site
3. Subject has skin infection, hypersensitive skin or skin allergies at potential implant sites
4. Subject is pregnant
5. Subject has Body Mass Index > 50
6. Subject has known bleeding disorder based on medical history and clinical observations, e.g., low platelet count
(<50,000), hypercoagulable state, e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating Lupus anticoagulant; active heparin-induced thrombocytopenia; Protein C or S deficiency; or history of recurrent deep vein thrombosis not related to AV access.
7. Subject has active malignancy, e.g., condition either being treated or considered untreatable
8. Subject has active systemic infection, e.g., condition either being treated or considered untreatable or positive blood culture
9. Subject has history of significant cardiovascular event/intervention such as angioplasty or stent placement within the previous 3 months, or myocardial infarction within the previous 6 months.
10. Subject has history of significant peripheral vascular disease requiring a major intervention within the previous 3 months
11. Subject has history of significant neurovascular event such as a major intervention within the previous 3 months or stroke within the previous 6 months.
12. Subject has uncontrolled major symptomatic medical problem, e.g., undiagnosed severe pain, metabolic disturbance, fever, etc.
13. There is likelihood of poor compliance to required dialysis protocol, e.g., history of poor attendance to required clinic sessions or non-compliance to medication
14. Subject has mental incapacity; inability to understand treatment instructions
15. Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
16. Subject has known or suspected allergy to titanium

Study & Design

• Study Type: Observational
• Study Design: Not specified