Chronic Kidney Disease Trial, Recruiting NCT06516653 Sponsor: Laminate Medical Technologies Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT06516653
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are scheduled to have a new surgical connection made between an artery and vein in the wrist or upper arm area (called an AV fistula) for kidney dialysis, and who agree to take part in the study.
  • Men and women who are not pregnant.
  • People between 18 and 80 years of age.
  • People who are willing and able to attend follow-up appointments over 12 months, including being able to travel to the clinic.

Who may not be able to join:

  • People whose surgery would be a repair or revision of an existing AV fistula, rather than a completely new one.
  • People whose vein in the area being operated on is significantly narrowed (50% or more blocked), as shown on an ultrasound scan before surgery.
  • People whose blood vessels have an unusual shape or size that would prevent a special medical device called the VasQ from fitting properly.
  • People with a known narrowing or blockage in the large veins near the chest on the side being operated on.
  • People who already have stents or stent grafts in the area where the fistula would be created.
  • People who are planned to have an additional procedure to move the fistula closer to the skin surface after it is created.
  • People with a known blood clotting disorder.
  • People with a known allergy to a metal called nitinol.
  • People who are expected to receive a kidney transplant within 12 months of joining the study.
  • People who are unable to give consent or are unable to attend the required follow-up visits.
  • People whose health outlook may not allow them to complete the full 12-month study period.
  • People who are already participating in another clinical study that could interfere with this trial's results, in the opinion of the study doctor.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: John F Lucas III, MD FACS FSVS, Greenwood Leflore Hospital

Phone: +972-3-6344246

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Laminate Medical Technologies
Registry
ClinicalTrials.gov
Start date
13 January 2025
Est. completion
1 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Fistula functional success

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov