Origin Intubation System for Improved Airway Management
Origin Intubation System
Device Feasibility Study
Summary
Study start date: October 1, 2025
Actual date on which the first participant was enrolled.The study is focused on testing a new medical device called the Origin Intubation System, designed to help doctors manage patients' airways more easily during procedures that require intubation, which is the process of inserting a tube into a person's airway to help them breathe. This system uses a special design inspired by how vines grow, allowing a soft tube to extend and navigate through the airway using low air pressure. This innovative approach aims to make intubation less traumatic and quicker by reducing the need for doctors to have an advanced knowledge of anatomy and by lessening the reliance on visualization tools, which can be challenging to use in complex situations. The study targets healthcare providers who perform intubation, aiming to improve patient care by making the process more efficient and accessible. The study involves using the Origin Intubation System on patients who need intubation. Participants in the study will experience the device's semi-self-navigation capabilities, which means the tube can guide itself with minimal manual intervention, potentially making the process smoother and faster. Researchers will evaluate how well the device works, focusing on its ability to safely and effectively place the tube in the airway. The study is interventional, meaning it involves actively testing the device on patients, and is in the early stages of research. The primary goal is to determine how feasible and effective this new technology is in real-world medical settings, though specific outcome measures are not detailed in this description.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: 1. Male or Female subjects 18 years of age or older and less than 75. 2. English or Spanish Speaking. 3. Undergoing elective surgery requiring endotracheal intubation. 4. Use of general anesthesia. Exclusion Criteria: 1. Patients with high aspiration risk. 2. Inability to provide informed consent in English or Spanish 3. Patients for whom an awake intubation is indicated and planned. 4. Patients with a history of head and neck radiation. 5. Pregnant patients. 6. Patients with BMI \>35 7. ASA 4 or higher 8. Patients who the investigator deems ineligible at the investigator's discretion. 9. Planned post-operative intubation. 10. Current incarceration.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location