STARgraft (10401) Pilot
ConditionEnd Stage Kidney Disease (ESRD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHealionics Corporation
About this trial
This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft.
The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft. The study proposes to evaluate the performance of the investigational STARgraft (10401) compared to the ePTFE controls in a prior study (NCT03916731) and to published results, over a period of 6 months. Additional data out to 36 months post-implantation may be captured.
Eligibility criteria
Qualifiers
Adult patients, 18 years or older.
Patient has given informed consent to participate in the trial.
Stated willingness to comply with all trial procedures and availability for the duration of the trial.
Able to effectively communicate with trial personnel.
Disqualifiers
Unable or unlikely to comply with trial protocol and/or follow-up.
Pregnancy.
Previous history of Peritoneal Dialysis treatment within the last 2 months
Central venous catheter located on same side as intended implant location.
Trial design
Treatments tested in this trial
- STARgraft (10401)
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
1Italian Hospital Asunción Paraguay
Sponsors and collaborators
Healionics Corporation
Lead sponsor
Source ClinicalTrials.gov