| NCT ID | NCT06759389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CoLabs Medical |
| Condition | Cardiac Arrest (CA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-04-04 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-04-04 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Jignesh Patel, M.D., M.Sc.
PRINCIPAL INVESTIGATOR
Stony Brook University Hospital
Frequently Asked Questions
Who can join the NCT06759389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Cardiac Arrest (CA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06759389 currently recruiting?
Yes, NCT06759389 is actively recruiting participants. Contact the research team at clayn@colabsmedical.com for enrollment information.
Where is the NCT06759389 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT06759389 clinical trial?
NCT06759389 is sponsored by CoLabs Medical. The principal investigator is Jignesh Patel, M.D., M.Sc. at Stony Brook University Hospital. The trial plans to enroll 25 participants.