End Stage Renal DiseasePhase 2/3SAVENCT01471041
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
A Phase 2/3 study testing Venous Window Needle Guide in people with End Stage Renal Disease and AV Fistula, run by Vital Access Corp. at 2 sites in United States.
Trial summary
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, AV Fistula, Kidney Failure
- What is being tested?
- Venous Window Needle Guide
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Jun 2013
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deep, uncannulatable, upper extremity arteriovenous fistula
- Minimum arteriovenous fistula flow 400 ml/min
- One year life expectancy
Who cannot join
- Non-transposed basilic or brachial vein arteriovenous fistula
- History of peripheral vascular disease
- History of cardiovascular disease
- History of cerebral vascular disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ladenheim Dialysis Access Centers
Fresno, California, 93710
University of Oklahoma - Tulsa
Tulsa, Oklahoma, 74104
About this study
Official title: Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
- Conditions
- End Stage Renal Disease, AV Fistula, Kidney Failure
- Being tested
- Venous Window Needle Guide
- Keywords
- End Stage Renal Disease, Hemodialysis, AV fistula, Kidney failure
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Window Needle GuideDevice
Also called VWNG
Subcutaneous, extravascular needle guide made of medical-grade titanium
| Study group | Role | What they receive |
|---|---|---|
| Venous Window Needle Guide | Experimental | Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Receives: Device: Venous Window Needle Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis
Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.
Measured: 3 months
Secondary outcomes (1)
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide
Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Access Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Crawford, BA, Study director, Vital Access
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471041
- Sponsor's protocol ID
- VA 024
- Acronym
- SAVE
- Status last verified
- Apr 2016
- First submitted
- 1 Nov 2011
- Last updated
- 3 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jennings WC, Galt SW, Shenoy S, Wang S, Ladenheim ED, Glickman MH, Kathuria P, Browne BJ. The Venous Window Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas. J Vasc Surg. 2014 Oct;60(4):1024-32. doi: 10.1016/j.jvs.2014.04.016. Epub 2014 May 13.
PubMed 24833247
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial
- ClinicalTrials.gov ID
- NCT01471041
- Acronym / sponsor ID
- SAVE / VA 024
- Conditions
- End Stage Renal Disease, AV Fistula, Kidney Failure
- Keywords
- End Stage Renal Disease, Hemodialysis, AV fistula, Kidney failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Vital Access Corp.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Posted 3 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venous Window Needle Guide | Experimental | Device: Venous Window Needle GuideVenous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Deep, uncannulatable, upper extremity arteriovenous fistula
- Minimum arteriovenous fistula flow 400 ml/min
- One year life expectancy
Key exclusion criteria (4 listed)
- Non-transposed basilic or brachial vein arteriovenous fistula
- History of peripheral vascular disease
- History of cardiovascular disease
- History of cerebral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous Window Needle GuideAlso: VWNGSubcutaneous, extravascular needle guide made of medical-grade titanium | Device | Venous Window Needle Guide |
Primary outcome
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis
Time frame: 3 months
Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.
1 secondary outcome
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24833247Jennings WC, Galt SW, Shenoy S, Wang S, Ladenheim ED, Glickman MH, Kathuria P, Browne BJ. The Venous Window Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas. J Vasc Surg. 2014 Oct;60(4):1024-32. doi: 10.1016/j.jvs.2014.04.016. Epub 2014 May 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Crawford, BA study director
Vital Access
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Venous Window Needle Guide in people with End Stage Renal Disease and AV Fistula, run by Vital Access Corp. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.