Evaluating the Entarik Feeding Tube System for airway detection
Airway Data Collection With the Entarik Feeding Tube System
This study is testing a new feeding tube system to see if it can safely detect the airway during bronchoscopy procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Theranova, L.L.C. Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06760572 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the airway detection performance of the Entarik Feeding Tube System during elective bronchoscopy procedures. Participants will have the feeding tube placed into the airway through an endotracheal tube while data on temperature and impedance are collected by the Entarik monitor. The study is designed as a prospective, single center, non-blinded, single arm approach, focusing on data collection for device development. The goal is to enhance the safety and effectiveness of feeding tube placement in the airway.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective bronchoscopy who will be intubated as part of standard care.
Not a fit: Patients with major upper airway malformations, significant respiratory infections, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and reliability of feeding tube placements in patients undergoing bronchoscopy.
How similar studies have performed: While this approach is innovative, similar studies focusing on airway detection and feeding tube safety have shown promise in enhancing procedural outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. At least 18 years old. 2. Able to provide informed consent. 3. Adults scheduled to undergo a bronchoscopy procedure who will be intubated as part of the standard of care. Exclusion Criteria: 1. Known major upper airway malformation. 2. Presence of clinically significant respiratory infection. 3. Known bleeding disorder. 4. Currently pregnant. 5. Current basilar skull fracture. 6. Known sensitivities or allergies to the feeding tube components. 7. Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination.
Where this trial is running
Philadelphia, Pennsylvania
- Temple University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Aaron Miller
- Email: clinicalstudy@theranova.com
- Phone: 415-926-8616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.