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| ID | Type | Description | Link |
|---|---|---|---|
| Pathfinder Medical | Other Identifier | The study is funded only by Pathfinder Medical and is not listed in any other databases. |
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| Name | Class |
|---|---|
| MINSA SA | UNKNOWN |
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The goal of this study is to evaluate the safety and effectiveness of the ePATH system in the creation of an endovascular AVF (endoAVF) in patients who require or will soon require hemodialysis and are eligible for a fistula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | An endoAVF will be created in the treated subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePATH System will be used to create an endoAVF | Device | An endoAVF will be created in subjects that need fistulas for hemodialysis |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Proportion of patients that experience one or more serious ePATH device-related or ePATH portion of the procedure-related adverse events during the first 3 months following AVF creation. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Technical success: Successful creation of a fistula with the ePATH system. Verification that an endoAVF has been created with the ePATH system and that it remains patent 1-7 days after the index procedure. Patency will be defined by an experienced examiner as the presence of a bruit as detected by stethoscope, or the presence of a thrill, or with duplex ultrasonography for all study endpoints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sorin C Popa, BESc, MRes | Contact | +44 (0) 7939186529 | sorin@pathfindermed.com |
| Name | Affiliation | Role |
|---|---|---|
| Adrian A Ebner, MD | Sanatorio Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatorio Italiano | Asunción | 001207 | Paraguay |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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An endoAVF for dialysis access will be created in the treated subjects.
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| 7 days |
| AVF maturation | Defined as an AVF that is free from stenosis or thrombosis with an arterial inflow of at least 500 ml/min and/or a diameter of at least 4 mm (as measured by duplex ultrasonography) or the patient was successfully dialysed with 2 needles. | 3 months |
| Time to fistula maturation | Number of days between the index procedure and the date at which AVF maturation is achieved | 3 months |
| Rate of other device or other procedure-related adverse events | Rate of serious other device (not ePATH device) or other procedure-related (not ePATH portion of the procedure) adverse events at 3 months following the index procedure | 3 months |
| Rate of device and/or procedure related infections | Rate of device and/or procedure related infections at 3 months following the index procedure | 3 months |
| D052776 |
| Female Urogenital Diseases |
| 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 |
| D020763 | Pathological Conditions, Anatomical |