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Origin Intubation System for Improved Airway Management

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What is being tested

Origin Intubation System

Device
Who is being recruted

Device Usability

From 18 to 75 Years
+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Device Feasibility Study

Early Phase 1
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorStanford University
Study ContactDr. Amit Saxena
Last updated: September 23, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual 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.

Official TitleClinical Evaluation of the Origin Intubation System 
Principal SponsorStanford University
Study ContactDr. Amit Saxena
Last updated: September 23, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
15 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Device Feasibility Study
These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Device Usability
Criteria
4 inclusion criteria required to participate
Male or Female subjects 18 years of age or older and less than 75
English or Spanish Speaking
Undergoing elective surgery requiring endotracheal intubation
Use of general anesthesia
10 exclusion criteria prevent from participating
Patients with high aspiration risk
Inability to provide informed consent in English or Spanish
Patients for whom an awake intubation is indicated and planned
Patients with a history of head and neck radiation

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
The Origin Intubation System will be utilized on participants undergoing general anesthesia for surgery.
Study Objectives
Primary Objectives

The time needed for intubation.
Secondary Objectives

Ability to intubate with the device the first time of use on a given participant.

Whether or not the clinician is able to intubate using the Origin Intubation System.

Adverse events associated with use of experimental device.

Usability of experimental device.

Participant feedback on experimental device, if any.

Mallampati, thyromental distance, etc.

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
Suspended
Stanford UniversityStanford, United StatesSee the location
Recruiting soonOne Study Center