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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venous Window Needle Guide | Experimental | Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous Window Needle Guide | Device | Subcutaneous, extravascular needle guide made of medical-grade titanium |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Crawford, BA | Vital Access | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ladenheim Dialysis Access Centers | Fresno | California | 93710 | United States | ||
| University of Oklahoma - Tulsa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24833247 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Venous Window Needle Guide | Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ESRD patients treated with HD having a deep, uncanulatable AVF
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| ID | Title | Description |
|---|---|---|
| BG000 | Venous Window Needle Guide | Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 3 months |
|
|
6 mths
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Venous Window Needle Guide | Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stenosis at VWING | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infiltration | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Crawford | Vital Access | 8014339390 | mcrawford@vital-access.com |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D001164 | Arteriovenous Fistula |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Tulsa |
| Oklahoma |
| 74104 |
| United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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 | Posted | Number | participants | 6 months |
|
|
|
| 8 |
| 54 |
| 44 |
| 54 |
| Cannulation pain resulting in VWING removal | Blood and lymphatic system disorders | Systematic Assessment |
|
| Inability to cannulate resulting in VWING removal | Blood and lymphatic system disorders | Systematic Assessment |
|
| Sepsis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Unable to cannulate | Blood and lymphatic system disorders | Systematic Assessment |
|
| Stenosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Thrombus | Blood and lymphatic system disorders | Systematic Assessment |
|
| Seroma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bruising | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pain | Blood and lymphatic system disorders | Systematic Assessment |
|
| Possible dislodge VWING | Blood and lymphatic system disorders | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bleeding following cannulation | Blood and lymphatic system disorders | Systematic Assessment |
|
| Incision dehiscence | Blood and lymphatic system disorders | Systematic Assessment |
|
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |