Clinical Trial

The SATURİSTA Device

Study acronym: SATURİSTA
Active, Not Recruiting
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Record status
This record was last updated May 8, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to evaluate the functional performance and feasibility of the Saturista system, a novel device designed for automated oxygen flow regulation based on continuous monitoring of oxygen saturation (SpO₂). The system integrates real-time physiological monitoring, wireless data transmission, and centralized visualization to support timely detection of oxygen desaturation and clinical decision-making. A pilot feasibility study will be conducted in healthy volunteers using a scenario-based protocol, including baseline monitoring, controlled desaturation, probe disconnection, and signal recovery. The primary objective is to assess the system's ability to generate alarms in response to changes in SpO₂ and to display data in real time. Secondary objectives include evaluation of response time, signal management, and overall system stability.
Trial Details
NCT Number NCT07576946
Lead Sponsor Koç University
Collaborators: Health Institutes of Turkey, Istinye University
Conditions Oxygen Therapy
Enrollment 7 participants
Start Date 2026-03-15
Primary Completion 2026-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-08