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The trial is taking place at:
T

Trinity Research Group | Dothan, AL

Veeva-enabled site

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial (MAFASA)

S

Sonavex

Status

Enrolling

Conditions

Diabetes
End Stage Renal Disease

Treatments

Device: EchoMark/EchoSure
Procedure: Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT06190717
MAFASA-2023

Details and patient eligibility

About

This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation.

Enrollment

304 estimated patients

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent.
  • Subject is able and willing to provide written informed consent prior to receiving any non-standard of care, protocol specific procedures.
  • Subject is willing and capable of complying with all required follow-up visits.
  • Subject and/or Care Team agree that the distance and transportation resources from the patient's home to the clinic are reasonable for study participation and compliance.
  • Subject has an estimated life expectancy > 18 months.
  • Subject is ambulatory (cane or walker are acceptable).
  • CKD Stage 5 (eGFR less than 10) or ESRD subjects presenting for upper arm autologous arteriovenous fistula creation that is not transposed for hemodialysis access.
  • Subjects who are currently on dialysis through a CVC or who imminently require dialysis (GFR <10).
  • Vein diameter ≥ 2.5 mm at the antecubital fossa per vein mapping.
  • Artery diameter ≥ 2.5 mm per vein mapping.
  • Subject is not participating in another investigational clinical trial that has not met its primary end point. Participation in post-market registry is acceptable.

Exclusion criteria

  • CKD Stage 1-4 or subjects that do not require upper arm autologous arteriovenous fistula creation for hemodialysis access.
  • Subject has history of Steal Syndrome.
  • Subject who is immunocompromised or immunosuppressed.
  • Subject has had three previous failed AV fistulae for hemodialysis access.
  • Subjects expecting to undergo major surgery within 60 days from the EchoMark implantation.
  • Known or suspected active infection on the day of the index procedure.
  • Subjects who had infection(s) in the 30-day window prior to EchoMark placement to reduce the likelihood of partially treated infections that can seed the device and fistula.
  • Subjects with diagnosed bleeding disorder, thrombocytopenia (platelet count <50,000), hypercoagulability, and history of recurrent deep vein thrombosis not related to AV access.
  • Subjects with active malignancy.
  • Subjects with a history of poor compliance with the dialysis protocol.
  • Subjects with a known or suspected allergy to any of the device materials.
  • Subjects with an existing fistula or graft.
  • Subjects who are anticipated to convert to peritoneal dialysis or undergo a transplant within 6 months.
  • Subjects who are pregnant, planning on becoming pregnant, or are breast feeding.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

304 participants in 2 patient groups

Diagnostic Arm
Experimental group
Description:
All subjects will have the EchoMark implanted. Subjects will be assessed every 2 weeks (+/- 1 week) (but no more frequently than weekly) with the EchoSure system until fistula maturation occurs and/or permanent access use is achieved.
Treatment:
Device: EchoMark/EchoSure
Standard of Care
Active Comparator group
Description:
Subjects will be evaluated per KDOQI guidelines (with physical examination at approximately 2 weeks (+/- 1 week) and between 4 and 6 weeks (+/- 1 week)). If evaluation yields abnormal findings, subjects will receive a Duplex ultrasound assessment (DUS). All SOC Arm subjects will be followed per the institution's standard of care until fistula maturation occurs and/or permanent access use is achieved but no more frequently than once per month.
Treatment:
Procedure: Standard of Care

Trial contacts and locations

8

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Central trial contact

Katy Feeny

Data sourced from clinicaltrials.gov

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