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The SATURİSTA Device

NCT07576946 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Oxygen Therapy

Sponsors & Collaborators

  • Health Institutes of Turkey

    collaborator OTHER_GOV

  • Istinye University

    collaborator OTHER

  • Koç University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07576946 on ClinicalTrials.gov