Clinical Evaluation of the Origin Intubation System

NCT ID: NCT07189182

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-09-01

Brief 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

Device Usability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Use of the Origin Intubation System

The Origin Intubation System will be utilized on participants undergoing general anesthesia for surgery.

Group Type: EXPERIMENTAL

Origin Intubation System

Intervention Type: DEVICE

This device leverages self-deploying geometry to guide intubation.

Interventions

Origin Intubation System

This device leverages self-deploying geometry to guide intubation.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Amit Raj Saxena

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Dr. Amit Saxena

Role: CONTACT

arsaxena@stanford.edu

(650) 723-6411

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

Role: CONTACT

sgaston@stanford.edu

650-714-2542

Facility Contacts

Human Subjects Research Compliance Office (IRB)

Role: primary

1-866-680-2906

References

Wang HE, Schmicker RH, Daya MR, Stephens SW, Idris AH, Carlson JN, Colella MR, Herren H, Hansen M, Richmond NJ, Puyana JCJ, Aufderheide TP, Gray RE, Gray PC, Verkest M, Owens PC, Brienza AM, Sternig KJ, May SJ, Sopko GR, Weisfeldt ML, Nichol G. Effect of a Strategy of Initial Laryngeal Tube Insertion vs Endotracheal Intubation on 72-Hour Survival in Adults With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2018 Aug 28;320(8):769-778. doi: 10.1001/jama.2018.7044.

Reference Type: BACKGROUND

PMID: 30167699 (View on PubMed)

Karamchandani K, Wheelwright J, Yang AL, Westphal ND, Khanna AK, Myatra SN. Emergency Airway Management Outside the Operating Room: Current Evidence and Management Strategies. Anesth Analg. 2021 Sep 1;133(3):648-662. doi: 10.1213/ANE.0000000000005644.

Reference Type: BACKGROUND

PMID: 34153007 (View on PubMed)

Other Identifiers

80068

Identifier Type: -

Identifier Source: org_study_id