EndoForce Post Approval Study
ConditionEnd Stage Renal Disease (ESRD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPhraxis, Inc.
About this trial
The goal of this observational study is to collect long-term safety and performance data for the use of the EndoForce System for connecting a hemodialysis graft to a vein in patients with End Stage Renal Disease. This is not an experimental procedure or an experimental therapy. This means that the study device has been approved by the FDA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is ≥18 years of age.
Patient requires the creation of a vascular access graft for hemodialysis, secondary to a diagnosis of ESRD.
Patient is able to have the vascular access ePTFE graft placed in an upper arm.
Patient or his/her legal guardian understands the study and is willing and able to comply with the dialysis schedule and follow-up requirements.
Disqualifiers
All contraindications for the EndoForce Connector System according to the IFU.
Patient is pregnant.
Patient is enrolled in another dialysis or vascular investigational study, without prior approval from the Sponsor.
Trial population
Patients with end stage renal disease requiring hemodialysis
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: EndoForce
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
All device and/or procedure-related events and all major adverse events that reasonably suggest the involvement of the EndoForce and that require or result in any of the following: death, emergent surgery, events requiring hospitalization, events requiring percutaneous interventions, vascular access infection requiring treatment, significant bleeding, pseudoaneurysm and serious adverse events. EndoForce migration, inadequate seal and leakage will also be collected acutely and at each in-person follow-up visit.
Time frame
2 years2
AVG Cumulative Patency
The percentage of subjects free from loss of access of the study graft for hemodialysis.
Time frame
2 years3
AVG Primary Patency
The percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency.
Time frame
2 years4
Number of AVG Interventions to Maintain Patency
The number of AVG interventions until access abandonment or through study completion.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov