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NCT07058610: Amplifi FIH
Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
NA trial testing Amplifi Vein Dilation System in End-Stage Renal Disease Requiring Haemodialysis in 19 participants. Completed in 11 June 2025.
11 June 2025
Quick facts
| Lead sponsor | Amplifi Vascular, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 8 December 2020 |
| Primary completion | 11 June 2025 |
| Estimated completion | 11 June 2025 |
| Sites | 1 location across Paraguay |
Drugs / interventions tested
- Amplifi Vein Dilation System
Conditions studied
- End-Stage Renal Disease Requiring Haemodialysis — all drugs for End-Stage Renal Disease Requiring Haemodialysis →
Sponsor
Amplifi Vascular, Inc.
Who can join
18 and older, any sex, with End-Stage Renal Disease Requiring Haemodialysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07058610
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07058610 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amplifi Vascular, Inc.
- Last refreshed: 2 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07058610.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing