Is NCT07211035 recruiting in Boston, MA?

Yes, NCT07211035 is currently recruiting participants at its Boston, MA location. This end stage kidney disease (esrd) clinical trial is actively enrolling qualified participants.

How do I join the end stage kidney disease (esrd) clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

End Stage Kidney Disease (ESRD) Clinical Trial in Boston, MA

About This End Stage Kidney Disease (ESRD) Study in Boston

The AMPLIFI-1 Study is a prospective, multicenter pivotal clinical trial designed to evaluate the safety and effectiveness of the Amplifi™ Vein Dilation System in patients requiring distal arteriovenous fistula (AVF) creation for hemodialysis. The study has two cohorts: a randomized controlled (RC) cohort of patients with suitable cephalic veins (≥2.5 mm) randomized 2:1 to Amplifi treatment plus AVF creation versus standard AVF creation alone, and a non-randomized small vein cohort (NRC) of patients with borderline veins (1.7 to \<2.5 mm) treated with Amplifi therapy followed by AVF creation.

Sponsor: Amplifi Vascular, Inc.

Who Can Participate

Inclusion Criteria

Age ≥ 18 years

Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice

End-Stage Renal Disease (ESRD) receiving maintenance hemodialysis.

Baseline cephalic vein diameter between \>1.7 mm and \<3.2 mm at the proposed Study AVF creation site in the distal forearm, with a continuous distal segment or tributary suitable for Amplifi System Outflow Catheter placement, including:

A forearm cephalic vein segment of ≥ 14 cm in length that provides an approximately 10 cm cannulation zone, free of detectable occlusions or stenosis, with collaterals.

Central continuity of the forearm cephalic vein at the elbow demonstrated through one or any combination of the following pathways:

the upper arm cephalic vein,

the median cubital vein connecting to the upper arm basilic vein,

the perforator vein connecting to the deep venous system.

Upper arm veins must show central continuity with no detectable occlusions.

Palpable radial artery with a diameter of ≥ 2.0 mm at the site of proposed AVF creation without significant stenosis along the course

Positive Allen's Test

At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion

Subject has voluntarily signed written informed consent

Exclusion Criteria

Known allergy to Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban

Known or suspected active infection at the proposed time of Amplifi System placement

Known bleeding diathesis, including from uncorrected coagulopathy

Known thrombophilia, requiring treatment

Hb \<7 gm/dL

Platelet level \< 100,000 /mm3

Significant radial artery calcification

Need for continued treatment with anti-platelet agents or other anticoagulants (other than apixaban) during the Amplifi System treatment period

Known history of patent foramen ovale \> 2 mm

History of recent intracranial or gastrointestinal bleeding

Documented recent central venous or right atrial thrombus

Known presence or recent history of intracranial or gastrointestinal bleeding or presence of underlying conditions that would predispose to intracranial or internal bleeding. Documented recent central venous or right atrial thrombus

History of recent ipsilateral central venous occlusion, stenosis \> 50%, angioplasty, or stent placement

Pregnancy, lactation, or plans to become pregnant during the Study

Expected survival less than 12 months

Unwillingness or inability to comply with procedures specified in the Protocol, or difficulty or inability to return for follow-up visits as specified by the Protocol

Participation in any other investigational drug or medical device study that has not completed primary endpoint evaluation or clinically interferes with the endpoints from the Study, or planned future participation in such studies prior to the completion of the Study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07211035) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

End Stage Kidney Disease (ESRD) Treatment Options in Boston, MA

If you're searching for end stage kidney disease (esrd) treatment options in Boston, MA, this clinical trial (NCT07211035) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced end stage kidney disease (esrd) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all end stage kidney disease (esrd) clinical trials near you to find additional studies recruiting in your area.

End Stage Kidney Disease (ESRD) Clinical Trial in Boston, MA

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