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NCT Number: NCT07189182

Clinical Evaluation of the Origin Intubation System

There are currently two options that are utilized are artificial airways in the operating room as well in emergency medicine: the endotracheal tube and the supraglottic airway. However, with these devices, healthcare professionals often experience difficulty and/or failure in utilizing these devices during their first-pass at intubation. Additionally, military medics often forego intubation in favor of basic life support during prolonged resuscitation. This study aims to test a device, one that has been tested in over 100 cadavers, to determine if it is a viable and safer/more successful option for intubation.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University

Stanford, California, 94305, United States

Location contact

Human Subjects Research Compliance Office (IRB)

CONTACT

1-866-680-2906

About this study

While previous attempts to address the challenge of airway management involve improved visualization tools (still requiring advanced anatomical knowledge), the focus of this clinical study is to evaluate the performance of the Origin Intubation System, which leverages self-deploying geometry to guide intubation. The enabling technology is vine-inspired tip-growth, in which a soft tube extends from its tip into potentially complex shapes, driven only by a low internal air pressure. This paradigm enables a novel device design that aids in intubation through semi-self-navigation, which is resilient to difficult visualization or user skill, is significantly less traumatic compared to existing methods; and fast (because it does not require the user to identify and navigate the internal anatomy).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Pregnant patients.
  • Patients with BMI >35
  • ASA 4 or higher
  • Patients who the investigator deems ineligible at the investigator's discretion.
  • Planned post-operative intubation.
  • Current incarceration.

Treatment and study plan

Origin Intubation System

Device

This device leverages self-deploying geometry to guide intubation.

Primary outcomes

  1. Overall intubation duration

    Time frame: Day of surgery.

    The time needed for intubation.

Secondary outcomes

  1. First-pass intubation success

    Time frame: Day of surgery.

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

  2. Overall intubation success

    Time frame: Day of surgery.

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

  3. Adverse events

    Time frame: From enrollment to follow-up period.

    Adverse events associated with use of experimental device.

  4. User assessment of intubation

    Time frame: Day of surgery.

    Usability of experimental device.

  5. Patient assessment of intubation

    Time frame: Day of surgery.

    Participant feedback on experimental device, if any.

  6. Patient airway characteristics

    Time frame: Day of surgery.

    Mallampati, thyromental distance, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Amit Saxena

CONTACT

[email protected]

(650) 723-6411

Samantha Gaston, B.S., B.A.

CONTACT

[email protected]

650-714-2542

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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