Study Results
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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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-04-04
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ventor
Subjects being treated with Ventor device
Resuscitation (Ventor)
Resuscitation with the Ventor device
Interventions
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Resuscitation (Ventor)
Resuscitation with the Ventor device
Eligibility Criteria
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Inclusion Criteria
2. IHCA (non-traumatic)
3. At least 4 feet in height
Exclusion Criteria
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
18 Years
75 Years
ALL
No
Sponsors
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CoLabs Medical
INDUSTRY
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIP 1.0
Identifier Type: -
Identifier Source: org_study_id
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