Xeltis Graft for Kidney Failure

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Xeltis

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults over 18 with end-stage kidney disease who need a graft for hemodialysis but can't have a fistula. They should have veins big enough for the graft, expect to live at least another year, understand the study and agree to follow-ups.

Inclusion Criteria

I understand the study and agree to participate.

I agree to follow-up visits before and after the procedure.

I am 18 years old or older.

See 3 more

Treatment Details

Interventions

Xeltis Hemodialysis Access (aXess) graft (Vascular Access Device)

Trial OverviewThe trial is testing the safety and performance of the Xeltis Hemodialysis Access (aXess) graft in patients needing dialysis access. It's a single-arm study, meaning all participants receive the same intervention without comparison to another group.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: aXess graftExperimental Treatment1 Intervention