Cardiac Arrest (CA)VENTORNCT06759389
The VENTOR Clinical Study
A study testing Resuscitation (Ventor) in people with Cardiac Arrest (CA), run by CoLabs Medical at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrest (CA)
- What is being tested?
- Resuscitation (Ventor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years, inclusive
- IHCA (non-traumatic)
- At least 4 feet in height
Who cannot join
- Intubated with an endotracheal tube (ET)
- Valid do-not-attempt-resuscitation (DNAR) or study opt-out bracelet (including previous enrollment bracelet)
- LAR or Family member objects to enrollment
- Obvious signs of irreversible death (rigor mortis, dependent lividity, decapitation, transection, decomposition)
- Responsive with an intact gag reflex
- Blunt, penetrating, or burn-related injury, drowning, or electrocution
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- Known upper airway foreign body or mass
- Lower airway obstruction
- Dental gap of < 2 cm
- Ingested caustic substances
- Medicine Admitting Note's medical history is incomplete or has only been completed by an emergency physician.
- Known esophageal disease or facial/perforating neck trauma defined as study candidates with the following medical history:
- Diseases: (Esophageal Varices, Esophageal Cancer, Esophageal Strictures)
- Any patient on the following medications will be excluded: (Oxaliplatin, Leucovorin, Fluorouracil)
- Any patient with the following examination findings will be excluded: (Caput medusae, History or evidence of vomiting blood)
- Known vulnerable subject other Inclusion #3, such as known (e.g.: prisoner, pregnancy, terminal illness, dementia)
- History of medical, surgical or other conditions that, in the opinion of the investigator, would limit study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Jacqueline Skarre, 631-444-9033, Jacqueline.Skarre@stonybrookmedicine.edu
Jignesh Patel, M.D., M.Sc.
About this study
Official title: The VENTOR Clinical Study - VENTilation and Airway Optimization for Cardiac Arrest Resuscitation
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.
- Conditions
- Cardiac Arrest (CA)
- Being tested
- Resuscitation (Ventor)
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitation (Ventor)Device
Resuscitation with the Ventor device
| Study group | Role | What they receive |
|---|---|---|
| Ventor | Experimental | Subjects being treated with Ventor device Receives: Device: Resuscitation (Ventor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to provide oxygenation during CPR
As measured through the monitoring of intra-arrest PaO2
Measured: From device insertion through 1 hour.
Ability to provide ventilation during CPR
As measured through the monitoring of intra-arrest PaCO2
Measured: From device insertion through 1 hour
Ability to provide oxygenation during CPR
As measured through the monitoring of intra-arrest cerebral oximetry
Measured: From device insertion through 1 hour
Number of participants with device-related adverse events
Number and rate of adverse events
Measured: From device insertion through 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start4 Apr 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CoLabs Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jignesh Patel, M.D., M.Sc., Principal investigator, Stony Brook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759389
- Sponsor's protocol ID
- CIP 1.0
- Acronym
- VENTOR
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VENTOR Clinical Study - VENTilation and Airway Optimization for Cardiac Arrest Resuscitation
- ClinicalTrials.gov ID
- NCT06759389
- Acronym / sponsor ID
- VENTOR / CIP 1.0
- Conditions
- Cardiac Arrest (CA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- CoLabs MedicalIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventor | Experimental | Device: Resuscitation (Ventor)Subjects being treated with Ventor device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-75 years, inclusive
- IHCA (non-traumatic)
- At least 4 feet in height
Key exclusion criteria (17 listed)
- Intubated with an endotracheal tube (ET)
- Valid do-not-attempt-resuscitation (DNAR) or study opt-out bracelet (including previous enrollment bracelet)
- LAR or Family member objects to enrollment
- Obvious signs of irreversible death (rigor mortis, dependent lividity, decapitation, transection, decomposition)
- Responsive with an intact gag reflex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resuscitation (Ventor)Resuscitation with the Ventor device | Device | Ventor |
Primary outcome
Ability to provide oxygenation during CPR
Time frame: From device insertion through 1 hour.
As measured through the monitoring of intra-arrest PaO2
Ability to provide ventilation during CPR
Time frame: From device insertion through 1 hour
As measured through the monitoring of intra-arrest PaCO2
Ability to provide oxygenation during CPR
Time frame: From device insertion through 1 hour
As measured through the monitoring of intra-arrest cerebral oximetry
Number of participants with device-related adverse events
Time frame: From device insertion through 3 months
Number and rate of adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jignesh Patel, M.D., M.Sc. principal investigator
Stony Brook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resuscitation (Ventor) in people with Cardiac Arrest (CA), run by CoLabs Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clay Nolan ((800) 592-6241, clayn@colabsmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to provide oxygenation during CPR (time frame: From device insertion through 1 hour.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.