The VENTOR Clinical Study

NCT ID: NCT06759389

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-04

Study Completion Date

2026-06-30

Brief Summary

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To evaluate the initial safety and effectiveness of the Ventor Airway System in providing short-term ventilation support in non-breathing subjects during cardiopulmonary resuscitation (CPR) and respiratory arrests.

Detailed Description

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Conditions

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Cardiac Arrest (CA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ventor

Subjects being treated with Ventor device

Group Type EXPERIMENTAL

Resuscitation (Ventor)

Intervention Type DEVICE

Resuscitation with the Ventor device

Interventions

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Resuscitation (Ventor)

Resuscitation with the Ventor device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 18-75 years, inclusive
2. IHCA (non-traumatic)
3. At least 4 feet in height

Exclusion Criteria

1. Intubated with an endotracheal tube (ET)
2. Valid do-not-attempt-resuscitation (DNAR) or study opt-out bracelet (including previous enrollment bracelet)
3. LAR or Family member objects to enrollment
4. Obvious signs of irreversible death (rigor mortis, dependent lividity, decapitation, transection, decomposition)
5. Responsive with an intact gag reflex
6. Blunt, penetrating, or burn-related injury, drowning, or electrocution
7. Known upper airway foreign body or mass
8. Lower airway obstruction
9. Dental gap of \< 2 cm
10. Ingested caustic substances
11. Medicine Admitting Note's medical history is incomplete or has only been completed by an emergency physician.
12. Known esophageal disease or facial/perforating neck trauma defined as study candidates with the following medical history:

1. Diseases: (Esophageal Varices, Esophageal Cancer, Esophageal Strictures)
2. Any patient on the following medications will be excluded: (Oxaliplatin, Leucovorin, Fluorouracil)
3. Any patient with the following examination findings will be excluded: (Caput medusae, History or evidence of vomiting blood)
13. Known vulnerable subject other Inclusion #3, such as known (e.g.: prisoner, pregnancy, terminal illness, dementia)
14. History of medical, surgical or other conditions that, in the opinion of the investigator, would limit study participation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CoLabs Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jignesh Patel, M.D., M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University Hospital

Locations

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Stony Brook University Hospital

Stony Brook, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clay Nolan

Role: CONTACT

(800) 592-6241

Facility Contacts

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Jacqueline Skarre

Role: primary

631-444-9033

Other Identifiers

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CIP 1.0

Identifier Type: -

Identifier Source: org_study_id

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