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Not Yet RecruitingNCT07189182

Clinical Evaluation of the Origin Intubation System

Status
Not Yet Recruiting
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
DEVICEOrigin Intubation SystemThis device leverages self-deploying geometry to guide intubation.

Timeline

Start date
2025-10-01
Primary completion
2026-09-01
Completion
2026-09-01
First posted
2025-09-23
Last updated
2025-09-23

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07189182. Inclusion in this directory is not an endorsement.