| 标题 |
Multicenter, Prospective, Comparative, Randomized, Single blind, Superior, Pivotal study to evaluate the clinical effectiveness and safety of respiratory rehabilitation software ‘Redpill Breath’ compared to the manual rehabilitation management for those needs respiratory rehabilitation(COPD, Asthma, Lung Cancer, etc.)
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| 其它 | INTERVENTION: Medical Device, Behavioral : 1. Test group: patients who use the software as the medical device for respiratory Rehabilitation at home. the medical device for the clinical trial 1) REDFILL SUMTOM/(LS‐ST‐001) (E10020.01[2], Respiratory Rehabilitation Software) 2) Intended use: REDFILL SUMTOM is intended for patients who are prescribed a respiratory rehabilitation exercise to improve their physical condition. The software also helps them to do self‐rehabilitation exercise. 3) Operation environment: Android (Software version: Android 8.0(API 26), Internal memory(HDD) 32GB or higher) or iOS (Software version: iOS 13.0, Internal memory(HDD) 32GB or higher) at least *Accessory used with the medical device: 1) WristOx2/(3150) (A17190.01[2], Pulse Oximeter) Total 54 (included extra one device per a clinical institution) 2. Control group: patients who are trained in |
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(2025-6-4)
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