The SATURİSTA Device (NCT07576946) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The SATURİSTA Device
Turkey (Türkiye)7 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy adult volunteers aged 18 years or older
* Resting oxygen saturation (SpO₂) within the normal range at baseline
* Ability to understand the study procedures and provide written informed consent
* Willingness to participate in all planned testing scenarios
Exclusion Criteria:
* History of chronic respiratory disease, including asthma, chronic obstructive pulmonary disease, or interstitial lung disease
* Known cardiovascular disease or any condition that may affect oxygen saturation or hemodynamic stability
* Current respiratory symptoms, acute infection, or fever at the time of participation
* Anemia, peripheral circulatory disorders, or any condition that may interfere with pulse oximetry measurements
* Skin lesions, deformity, or injury at the intended probe placement site
* Pregnancy
* History of syncope, intolerance to short-duration breath-holding, or any condition that may increase risk during testing
* Inability or unwillingness to comply with study procedures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Real-Time Data Display Performance
Timeframe: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session