Prospective multi-centre observational pilot study to investigate the safety and efficacy of the Venous Window Needle GuideTM (VWNG) (SAVE-2 study)
| ISRCTN | ISRCTN79284836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79284836 |
| Secondary identifying numbers | 14213 |
- Submission date
- 02/04/2014
- Registration date
- 29/07/2014
- Last edited
- 07/06/2017
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Haemodialysis is a treatment that replaces much of the work done by the kidneys. It filters the blood and gets rid of harmful waste, extra salt and water from the body. The treatment is literally a life-saver for patients with advanced kidney failure (where the kidney has stopped, or almost stopped, working). It requires ongoing and safe access to the patients bloodstream so that the blood can be removed, filtered and then returned to the body. An arteriovenous fistula (AV fistula), a blood vessel created by connecting an artery and a vein, is used for this purpose. However, in some cases, inserting a needle to get the blood out can be difficult, particularly if the AV fistula is in a deeper location. The problems this can cause can cancel out the benefits of creating the AV fistula. The main aim of this study is to test the long-term safety and performance of a new device called the Venous Window Needle GuideTM (VWNG) device designed to help with the needling of difficult-to-needle AV fistulae.
Who can participate?
Patients with problematic fistulas or patients wishing to self-cannulate (insert their own needles) and with a life expectancy of at least one year.
What does the study involve?
Participants have surgery to insert the VWNG device. The success of the procedure is assessed and all patients are followed up after a year.
What are the possible benefits and risks of participating?
The potential benefits for each participant is a AV fistula that works better. Risks include possible infection and bleeding.
Where is the study run from?
Central Manchester University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2013 to June 2014
Who is funding the study?
Vital Access Corporation (USA)
Who is the main contact?
Dr Sandip Mitra
Tel: 0161 276 6509
Contact information
Scientific
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
Study information
| Study design | Non-randomised; Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Prospective multi-centre observational pilot study to investigate the safety and efficacy of the Venous Window Needle GuideTM (VWNG) (SAVE-2 study) |
| Study acronym | SAVE-2 |
| Study objectives | The main aim of the study is to evaluate the long-term safety and efficacy of the VWNG device. The VWNG is a CE marked device and is intended to facilitate needling of difficult-to-needle dialysis fistulae. |
| Ethics approval(s) | NRES Committee North West - Greater Manchester South, 16/01/2013, ref: 12/NW/0869 |
| Health condition(s) or problem(s) studied | Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders |
| Intervention | The study aims to evaluate the use of the VWNG device when surgically applied to the arterial fistula. The patients will be followed up for 12 months. |
| Intervention type | Other |
| Primary outcome measure | 1. The primary safety endpoint is the rate of device or procedure-related serious adverse events 2. Depth and dimension of vessel and how problematic the fistula is, measured at baseline 3. Scan to assess patency and AVF flow at 3 and 12 months |
| Secondary outcome measures | N/A |
| Overall study start date | 10/06/2013 |
| Completion date | 10/06/2014 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Key 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. Subjects fistula diameter is at least 5 mm at the planned site of device attachment 4. Buttonhole cannulation technique is appropriate for the subject 5. Subjects 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. Subjects life expectancy is at least 1 year, based on clinicians 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 |
| Key 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 |
| Date of first enrolment | 10/06/2013 |
| Date of final enrolment | 10/06/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M13 9WL
United Kingdom
Sponsor information
Hospital/treatment centre
St Mary's Hospital
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom
| Website | http://www.cmft.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/06/2017: The study has been stopped due to difficulties in recruiting participants.
13/04/2017: No publications found in PubMed, verifying study status with principal investigator
