Propel Drug-Eluting Sinus Implant Family IBUKI Japan Cohort
Summary
A new observational clinical trial (NCT07546682) registered on ClinicalTrials.gov on April 23, 2026, evaluating the PROPEL family of drug-eluting sinus implants for clinical safety and performance in Japanese patients with Chronic Rhinosinusitis (CRS). The study is conducted under standard of care conditions with no active interventions — purely observational. The IBUKI cohort specifically confirms product performance when used according to Instructions for Use (IFUs) in Japan.
“To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.”
About this source
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What changed
This document registers a new observational clinical trial on ClinicalTrials.gov for the PROPEL family of drug-eluting sinus implants. The IBUKI Japan cohort study (NCT07546682) is designed to confirm clinical safety and performance when used according to IFUs and standard of care in Japan. The condition under study is Chronic Rhinosinusitis (CRS). There are no active interventions — the study is purely observational, following patients under standard treatment protocols.
Affected parties include sponsors conducting medical device clinical investigations in Japan and medical device manufacturers with products subject to post-market or confirmatory clinical evidence requirements. While this registration itself does not create compliance obligations, it signals continued regulatory and clinical interest in drug-eluting sinus implant technology in the Japanese market. Sponsors of similar CRS or ENT device studies should review their IFU compliance protocols given this study's stated objective of confirming use according to IFUs.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
Observational NCT07546682 Kind: OBSERVATIONAL Apr 23, 2026
Abstract
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.
Conditions: Chronic Rhinosinusitis (CRS)
Interventions: None, observational standard of care study
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