HealthyNCT06760572
Airway Data Collection With the Entarik Feeding Tube System
A study testing Airway insertion in people with Healthy, run by Theranova, L.L.C. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Airway insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2025to 12 Dec 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Able to provide informed consent.
- Adults scheduled to undergo a bronchoscopy procedure who will be intubated as part of the standard of care.
Who cannot join
- Known major upper airway malformation.
- Presence of clinically significant respiratory infection.
- Known bleeding disorder.
- Currently pregnant.
- Current basilar skull fracture.
- Known sensitivities or allergies to the feeding tube components.
- Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination.
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
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Sudhir Bolla, 215-707-8113, Sudhir.Bolla@tuhs.temple.edu
Gerard Criner, MD
About this study
The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.
Read the detailed description
The study is a prospective, single center, non-blinded, single arm study. Subjects who are scheduled to undergo an elective bronchoscopy procedure will have an Entarik Feeding Tube placed into the airway through an endotracheal tube under direct visualization while temperature and impedance data are collected by the Entarik monitor. Other data will be passively simultaneously collected through the Feeding Tube.
- Conditions
- Healthy
- Being tested
- Airway insertion
- Keywords
- Feeding Tube, feeding tube placement safety, feeding tube placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway insertionDevice
Tube will be inserted into the trachea to make airway data measurements.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Experimental | Airway insertion Receives: Device: Airway insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of accurate airway verifications by the Entarik feeding tube system
Percentage of accurate verifications of airway placement of the tip of the Entarik feeding tube at the Safety Check Depth.
Measured: During the airway placement procedure
Incidence of Adverse Events
Incidence of adverse events: (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the subject.
Measured: During the airway placement procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start13 Feb 2025
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Theranova, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Daniel Burnett, MD, Study director, Theranova, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760572
- Sponsor's protocol ID
- CRD-04-1877-01
- Other IDs
- R44AG076248
- Status last verified
- May 2025
- First submitted
- 31 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Demographics and Primary Endpoint results.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Data Collection With the Entarik Feeding Tube System
- ClinicalTrials.gov ID
- NCT06760572
- Acronym / sponsor ID
- CRD-04-1877-01
- Conditions
- Healthy
- Keywords
- Feeding Tube, feeding tube placement safety, feeding tube placement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Theranova, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 7 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.
The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.
Detailed description
The study is a prospective, single center, non-blinded, single arm study. Subjects who are scheduled to undergo an elective bronchoscopy procedure will have an Entarik Feeding Tube placed into the airway through an endotracheal tube under direct visualization while temperature and impedance data are collected by the Entarik monitor. Other data will be passively simultaneously collected through the Feeding Tube.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | Experimental | Device: Airway insertionAirway insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old.
- Able to provide informed consent.
- Adults scheduled to undergo a bronchoscopy procedure who will be intubated as part of the standard of care.
Key exclusion criteria (7 listed)
- Known major upper airway malformation.
- Presence of clinically significant respiratory infection.
- Known bleeding disorder.
- Currently pregnant.
- Current basilar skull fracture.
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 |
|---|---|---|
| Airway insertionTube will be inserted into the trachea to make airway data measurements. | Device | Healthy Adults |
Primary outcome
Percentage of accurate airway verifications by the Entarik feeding tube system
Time frame: During the airway placement procedure
Percentage of accurate verifications of airway placement of the tip of the Entarik feeding tube at the Safety Check Depth.
Incidence of Adverse Events
Time frame: During the airway placement procedure
Incidence of adverse events: (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the subject.
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 13 May 2025.
- Individual participant dataSharing planned: Yes. Demographics and Primary Endpoint results.
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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.
Daniel Burnett, MD study director
Theranova, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway insertion in people with Healthy, run by Theranova, L.L.C. 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 7 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 13 May 2025. 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 Aaron Miller (415-926-8616, clinicalstudy@theranova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of accurate airway verifications by the Entarik feeding tube system (time frame: During the airway placement procedure). The study lists 2 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 13 May 2025.