Healthy AdultsNCT06660758
Pilot Study of the Entarik System With Advanced Functionality in Health Adults
A study testing Feeding tube (Entarik) in people with Healthy Adults, run by Gravitas Medical, Inc. at 1 site in United States.
Trial summary
In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Feeding tube (Entarik)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2024to 22 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
- Capable and willing to follow all study-related procedures
- Confirmed fasted state for a minimum of 8 hours prior to study initiation
Who cannot join
- Inability to receive a feeding tube
- Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers
- Has a basilar skull fracture
- Self-reports pregnancy
- Deemed unsuitable for enrollment in study by the investigator based on subjects' history 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
Gravitas Medical, Inc.
Berkeley, California, 94710
Aaron Miller, 415-926-8616, clinicalstudy@theranova.com
Thomas Sorrentino, MD
About this study
In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.
- Conditions
- Healthy Adults
- Being tested
- Feeding tube (Entarik)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding tube (Entarik)Device
Feeding tube placement will be verified using multiple methods in the duodenum and stomach.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Experimental | An Entarik feeding tube will be introduced and subjects will receive a meal administered through the feeding tube. Ultrasound and other data will be recorded before, during and after the meal is administered. Receives: Device: Feeding tube (Entarik) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device-related adverse events
The incidence and severity of Adverse Events (AEs) including device and procedure-related AEs and the incidence and severity of Serious Adverse Events (SAEs) will be evaluated throughout the study.
Based on the non-invasive nature of the device and clinical experience gained to date, there are expected to be no SAEs nor Unanticipated Adverse Device Effects (UADEs) in the study. If any SAEs or UADEs occur they will be documented and reported, but there are no planned formal hypotheses associated with the evaluation of safety.
Measured: From enrollment to end of study (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start22 Oct 2024
- Primary completion21 Dec 2025 (estimated)
- Study completion22 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gravitas Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theranova, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Thomas Sorrentino, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660758
- Sponsor's protocol ID
- CRD-04-1934-01
- Status last verified
- Jul 2025
- First submitted
- 24 Oct 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a device development study. Subject data may be shared at a later time at the sponsor's discretion.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Entarik System With Advanced Functionality in Health Adults
- ClinicalTrials.gov ID
- NCT06660758
- Acronym / sponsor ID
- CRD-04-1934-01
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gravitas Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Theranova, L.L.C.
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 21 Dec 2025 (estimated)
- Study completion
- 22 Dec 2025 (estimated)
- First posted
- 28 Oct 2024 (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.
In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | Experimental | Device: Feeding tube (Entarik)An Entarik feeding tube will be introduced and subjects will receive a meal administered through the feeding tube. Ultrasound and other data will be recorded before, during and after the meal is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old
- Able to provide informed consent
- Capable and willing to follow all study-related procedures
- Confirmed fasted state for a minimum of 8 hours prior to study initiation
Key exclusion criteria (5 listed)
- Inability to receive a feeding tube
- Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers
- Has a basilar skull fracture
- Self-reports pregnancy
- Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
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 |
|---|---|---|
| Feeding tube (Entarik)Feeding tube placement will be verified using multiple methods in the duodenum and stomach. | Device | Healthy Adults |
Primary outcome
Freedom from device-related adverse events
Time frame: From enrollment to end of study (1 day)
The incidence and severity of Adverse Events (AEs) including device and procedure-related AEs and the incidence and severity of Serious Adverse Events (SAEs) will be evaluated throughout the study. Based on the non-invasive nature of the device and clinical experience gained to date, there are expected to be no SAEs nor Unanticipated Adverse Device Effects (UADEs) in the study. If any SAEs or UADEs occur they will be documented and reported, but there are no planned formal hypotheses associated with the evaluation of safety.
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 11 Jul 2025.
- Individual participant dataSharing planned: No. This is a device development study. Subject data may be shared at a later time at the sponsor's discretion.
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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.
Thomas Sorrentino, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding tube (Entarik) in people with Healthy Adults, run by Gravitas Medical, Inc. 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 4 inclusion and 5 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 11 Jul 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 Director of Clinical (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?
Freedom from device-related adverse events (time frame: From enrollment to end of study (1 day)). 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 11 Jul 2025.