Xeltis Hemodialysis Access Graft (aXess) US Study
Public ClinicalTrials.gov record NCT06494631. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.
Study identification
- NCT ID
- NCT06494631
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 140 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 11, 2024 (Actual)
- Primary completion
- Jan 2028 (Estimated)
- Completion
- Jan 2032 (Estimated)
- Last update posted
- Jul 29, 2026
2024 – 2032
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AKDHC Medical Research Services, LLC | Phoenix | Arizona | 85016 | — |
| AKDHC Medical Research Services, LLC | Tuscon | Arizona | 85718 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Greenwood Leflore Hospital | Greenwood | Mississippi | 38930 | — |
| Surgical Specialists of Charlotte | Charlotte | North Carolina | 28210 | — |
| Flow Vascular, Surgery Specialty Hospitals of America | Pasadena | Texas | 77504 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06494631, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06494631 live on ClinicalTrials.gov.