This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.
The Amplifi System was used to promote vein dilation prior to AVF creation. Subjects with ESRD or CKD were treated across three phases of enrollment. The protocol incorporated learnings from earlier phases, including improvements to the device design and procedural protocols. This registration covers all phases of the study (Phase 1-3), with updates planned as new data becomes available.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
An investigational extracorporeal blood pump and catheter system designed to promote vein dilation prior to AVF creation.
Sanatorio Italiano
Asunción, Paraguay
Rate of AVF Maturation at 2 and 6 Weeks
Time frame: From post AVF creation to end of 6 weeks follow-up.
Percent Change in Cephalic Vein Diameter and Blood Flow
Time frame: From baseline, during Amplifi System treatment (minimum daily), and prior to Amplifi System removal and AVF creation]
Mean vein diameter of the cephalic vein and blood flow of brachial artery
Time frame: 2 and 6 weeks post AVF creation
Percentage of subjects who experience an increase in the cephalic vein diameter of ≥2.7 mm from their baseline measurement, or an increase of >1 mm from baseline, following treatment with the Amplifi System.
Time frame: From baseline measurement to intra-procedural assessment immediately prior to Amplifi System removal and AVF creation (same procedure day)
Rate of Occurrence of Major Device-Related Adverse Events
Time frame: from device implantation and up to 30 days from device removal and AVF creation
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