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Diagnostic Arm for Kidney Failure (MAFASA Trial)

Q: Who would be the most suitable candidate to participate in this medical study?

Candidates eligible for participation in this clinical study must have kidney impairment and be aged between 18 and 84 years old. The trial aims to enroll approximately 304 individuals.

Q: What is the collective count of participants who are joining this medical research study?

Indeed, data from clinicaltrials.gov confirms that this investigation is actively seeking eligible participants. The trial was initially listed on February 21st, 2024 and its latest update was on February 26th, 2024. A total of 304 individuals are being sought at a single research site.

Q: Is the enrollment for this investigation currently open?

Indeed, information from clinicaltrials.gov confirms that this particular trial is actively seeking participants. The trial was initially posted on February 21st, 2024, and most recently revised on February 26th, 2024. A total of 304 patients are sought after at a single site for enrollment in the study.

Q: Does this study enroll individuals who are 18 years of age or older?

Candidates eligible for this research study must be between the ages of 18 and 84. Notably, there are a substantial number of clinical trials available for both pediatric patients under 18 years old as well as elderly individuals above 65 years old.

Q: What is the primary goal or purpose of this medical study?

As per the sponsor, Sonavex, Inc., the main outcome of interest over a 6-month duration is labeled as Primary Effectiveness Endpoint. Furthermore, secondary endpoints will cover metrics such as Discrepancy between EchoSure and Duplex Flow Measurements - defined as the variation in log10-transformed readings for blood flow assessment; Time taken for CVC Removal categorized by subject group; and Occurrence-free Period within 30 to 90 Days encompassing events like significant relocation or movement of the EchoMark implant, injuries related to tissue or vessels from the procedure requiring surgical correction, infections around the EchoMark necessitating intravenous <a href="https://www.withpower.com/clinical-trials/antibiotics">antibiotics</a>,

N/A

Recruiting

Research Sponsored by Sonavex, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is willing and capable of complying with all required follow-up visits

Males or non-pregnant, non-breastfeeding females ≥ 18 years of age but < 85 years of age at the time of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 4 months, 5 months, and 6 months

Awards & highlights

MAFASA Trial Summary

This trial will test a new ultrasound system called EchoMark®/EchoSure® to see if it can help assess the development of a fistula for dialysis access and reduce the time it takes for

Who is the study for?

This trial is for adults aged 18-85 with severe kidney issues who need dialysis, can walk (even with a cane or walker), and have veins big enough for an arteriovenous fistula. They should expect to live more than 18 months, be able to follow the study plan, and travel to the clinic.Check my eligibility

What is being tested?

The trial tests EchoMark/EchoSure System's ability to check how well a new blood vessel connection matures in patients needing dialysis. It compares regular care with biweekly ultrasound checks using this system.See study design

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, side effects may include discomfort or minor risks associated with frequent ultrasounds and standard care related to fistula management.

MAFASA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to attend all required follow-up visits.

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I am a man or a woman not pregnant or breastfeeding, aged 18 to 84.

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I can walk on my own or with the help of a cane or walker.

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I have advanced kidney disease and need a fistula for dialysis.

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I am on dialysis or will need it soon due to severe kidney issues.

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My vein in the elbow area is at least 2.5 mm wide.

MAFASA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 4 months, 5 months, and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 4 months, 5 months, and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 4 months, 5 months, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary outcome measures

AV Fistula Maturation Rate

CVC Removal

Difference between EchoSure and Duplex Flow Measurements

+6 more

Other outcome measures

Cannulation Complication Rates

Clinical Maturation

Comparision of Implant and Procedure Related Adverse Events

+13 more

MAFASA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Diagnostic ArmExperimental Treatment1 Intervention

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.

Group II: Standard of CareActive Control1 Intervention

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.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Sonavex, Inc.Lead Sponsor

3 Previous Clinical Trials

437 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be the most suitable candidate to participate in this medical study?

"Candidates eligible for participation in this clinical study must have kidney impairment and be aged between 18 and 84 years old. The trial aims to enroll approximately 304 individuals."

Answered by AI

What is the collective count of participants who are joining this medical research study?

"Indeed, data from clinicaltrials.gov confirms that this investigation is actively seeking eligible participants. The trial was initially listed on February 21st, 2024 and its latest update was on February 26th, 2024. A total of 304 individuals are being sought at a single research site."

Answered by AI

Is the enrollment for this investigation currently open?

"Indeed, information from clinicaltrials.gov confirms that this particular trial is actively seeking participants. The trial was initially posted on February 21st, 2024, and most recently revised on February 26th, 2024. A total of 304 patients are sought after at a single site for enrollment in the study."

Answered by AI

Does this study enroll individuals who are 18 years of age or older?

"Candidates eligible for this research study must be between the ages of 18 and 84. Notably, there are a substantial number of clinical trials available for both pediatric patients under 18 years old as well as elderly individuals above 65 years old."

Answered by AI

What is the primary goal or purpose of this medical study?

"As per the sponsor, Sonavex, Inc., the main outcome of interest over a 6-month duration is labeled as Primary Effectiveness Endpoint. Furthermore, secondary endpoints will cover metrics such as Discrepancy between EchoSure and Duplex Flow Measurements - defined as the variation in log10-transformed readings for blood flow assessment; Time taken for CVC Removal categorized by subject group; and Occurrence-free Period within 30 to 90 Days encompassing events like significant relocation or movement of the EchoMark implant, injuries related to tissue or vessels from the procedure requiring surgical correction, infections around the EchoMark necessitating intravenous antibiotics,"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial

2024. "Maturation of Arteriovenous Fistula With Automated Sonography Assessments Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06190717.