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| Name | Class |
|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez | OTHER |
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Feasibility clinical study to evaluate the safety and effectiveness of the catheter system for the percutaneous creation of an arteriovenous fistula for patients with end stage renal disease requiring dialysis access.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous creation of an arteriovenous fistula | Device | Use of catheter system for percutaneous creation of an arteriovenous fistula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Sufficient Patency for Clinical Access | Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate. | 6 weeks |
| Number of Patients Achieving Dialysis Access | Arteriovenous fistula is mature and patient has started dialysis using the fistula | 6 weeks |
| Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis | Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access | The number of patients requiring additional interventions to achieve maturation and initiation of dialysis. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Sufficient Patency for Clinical Access | Arteriovenous fistula is patent as determined by auscultation or ultrasound and eligible for maturation assistance to achieve clinical access flow rate. | Patency at 6 weeks | Posted | Count of Participants | Participants | 6 weeks |
|
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Adverse event data was collected over a period of 6 months from index procedure through arteriovenous fistula maturation
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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 | Treatment | Interventional use of experimental Ellipsys catheter system for percutaneous creation of an arteriovenous fistula Percutaneous creation of an arteriovenous fistula: Use of catheter system for percutaneous creation of an arteriovenous fistula |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Deaths during study duration. None related to treatment procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gene Reu | Avenu Medical - Sponsor | 949 276 2483 | 102 | greu@avenumedical.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Primary | Number of Patients Achieving Dialysis Access | Arteriovenous fistula is mature and patient has started dialysis using the fistula | Patients on dialysis at 6 weeks | Posted | Count of Participants | Participants | 6 weeks |
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|
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| Primary | Number of Patients on Dialysis Using the Arteriovenous Fistula or Has Adequate Access Flow Rate to Allow Dialysis | Arteriovenous fistula is mature or has achieved a minimum clinically acceptable access flow rate as determined by doppler ultrasound assessment to support dialysis | Patients on dialysis or achieved suitable access flow rate | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Number of Patients Requiring Additional Interventions to Achieve Maturation and Dialysis Access | The number of patients requiring additional interventions to achieve maturation and initiation of dialysis. | Number of additional interventions to achieve suitability for dialysis | Posted | Count of Participants | Participants | 12 weeks |
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| 9 |
| 23 |
| 0 |
| 23 |
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| Hematoma | Blood and lymphatic system disorders | Systematic Assessment | Hematoma associated with procedure |
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| Acute thrombosis | Vascular disorders | Non-systematic Assessment | Acute thrombosis of anastomosis |
|
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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 |