End Stage Renal Disease (ESRD)NCT07146854
EndoForce Post Approval Study
An observational study of End Stage Renal Disease (ESRD), run by Phraxis, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2026to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end stage renal disease requiring hemodialysis
Who may be able to join
- 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.
- Patient or his/her legal guardian provides written informed consent.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
MUSC Health Orangeburg
Orangeburg, South Carolina, 29118
Virginia Anderson, 803-395-3878, andersvi@musc.edu
Mark London, MD
- Recruiting
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Darla Howard, 864-590-5521, DHoward@srhs.com
Ari Kramer, MD
About this study
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.
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- Hemodialysis, Arteriovenous graft
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EndoForce | AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
AVG Cumulative Patency
The percentage of subjects free from loss of access of the study graft for hemodialysis.
Measured: 2 years
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.
Measured: 2 years
Number of AVG Interventions to Maintain Patency
The number of AVG interventions until access abandonment or through study completion.
Measured: 2 years
Number of Participants with Acute Device Success
AV graft flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery.
Measured: Through end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start13 Jan 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phraxis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ari Kramer, MD, Principal investigator, Spartanburg Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146854
- Sponsor's protocol ID
- 009-034
- Status last verified
- Jan 2026
- First submitted
- 21 Aug 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoForce Post Approval Study
- ClinicalTrials.gov ID
- NCT07146854
- Acronym / sponsor ID
- 009-034
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- Hemodialysis, Arteriovenous graft
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Phraxis, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoForce | – | –AV Graft implanted using the EndoForce Connector for Endovascular Venous Anastomosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage renal disease requiring hemodialysis
Key inclusion criteria (5 listed)
- 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.
- Patient or his/her legal guardian provides written informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 2 years
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.
AVG Cumulative Patency
Time frame: 2 years
The percentage of subjects free from loss of access of the study graft for hemodialysis.
AVG Primary Patency
Time frame: 2 years
The percentage of subjects free from the first occurrence of either access thrombosis or an access procedure performed to maintain access patency.
Number of AVG Interventions to Maintain Patency
Time frame: 2 years
The number of AVG interventions until access abandonment or through study completion.
Number of Participants with Acute Device Success
Time frame: Through end of procedure
AV graft flow at the end of the procedure as determined by palpable graft thrill and/or audible bruit, without significant bleeding or emergent surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ari Kramer, MD principal investigator
Spartanburg Regional Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease (ESRD), run by Phraxis, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Zentgraf (651-260-6673, jzentgraf@phraxis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.