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RECRUITING
NCT07025304
NA

Post-Market Clinical Study to Evaluate the Safety and Effectiveness of REFLEX ULTRA 45 for Coblation Inferior Turbinate Reduction in China

Sponsor: Smith & Nephew, Inc.

View on ClinicalTrials.gov

Summary

The study is a prospective, multi-center, post-market clinical study to evaluate the safety and effectiveness of REFLEX ULTRA 45 for the coblation inferior turbinate reduction in China. The study product is REFLEX ULTRA 45 (EIC4845-01/EICA4845-01). Also it needs to be performed with the controller system COBLATOR II or WEREWOLF. The sample size is 105 subjects with approximate 6 sites in China mainland.

Official title: A Prospective, Multi-center, Post-Market Clinical Study to Evaluate the Safety and Effectiveness of the REFLEX ULTRA 45 for the Coblation Inferior Turbinate Reduction in China

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

105

Start Date

2025-07-02

Completion Date

2028-06-30

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DEVICE

REFLEX ULTRA 45

One time use for surgery

Locations (6)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Sir Run Run Shaw Hospital Affiliated with Zhejiang University School of Medicine

Hangzhou, Zhejiang, China