Intubated PatientsNCT07806812
Pilot Study of the Sage Guard for Oral Cavity Protection
A study testing Sage Guard oral protection device in people with Intubated Patients, run by Wake Forest University Health Sciences.
Trial summary
The study will evaluate how safe the device is and how easy it is for healthcare providers to use in patients receiving care in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Intubated Patients
- What is being tested?
- Sage Guard oral protection device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2027to Nov 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Intubated ICU patients on mechanical ventilation
- 2 sets of opposing teeth that occlude on both left and right sides
- Attending physician requested a dental evaluation as part of the patient's care
Who cannot join
- Active oral infection or trauma preventing safe device placement
- Known allergy to thermoplastic polyurethane (TPU)
- Severe facial or jaw trauma incompatible with device placement
- Mixed dentition, primary dentition, and edentulous patients
About this study
Official title: Pilot Feasibility Study to Evaluate the Efficacy, Safety, and Usability of the Sage Guard for Protecting the Vital Structures of the Oral Cavity
The study will evaluate how safe the device is and how easy it is for healthcare providers to use in patients receiving care in the Intensive Care Unit (ICU).
Read the detailed description
A device will be placed in participants that are intubated in the ICU. The device will remain in place for up to 21 days, removal of the device will coincide with extubation. Surveys will be completed by experienced healthcare providers in the ICU to answer work related questions and provide a baseline for oral trauma in the ICU while intubated. Bedside nurses will be asked to answer questions about their experience with the device during participant use to understand ease of usability and integration into the workflow.
- Conditions
- Intubated Patients
- Being tested
- Sage Guard oral protection device
- Keywords
- endotracheal tube damage and clearance, Intensive care unit intubated patients, Intensive care unit oral trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sage Guard oral protection deviceDevice
The study device is a single-use mouth device made of a soft plastic material (thermoplastic polyurethane). It has side bite blocks that help keep the teeth apart, a center support that helps hold the breathing tube in place, and tongue guards that help protect the tongue from injury. The device is designed for use in patients with an endotracheal (breathing) tube to help prevent injury to the mouth and tongue caused by biting and to help keep the breathing tube stable.
| Study group | Role | What they receive |
|---|---|---|
| Sage Guard Intervention | Experimental | Participants will wear the Sage Guard device during the study procedure to evaluate its feasibility, safety, usability, and effectiveness in protecting vital structures of the oral cavity. Receives: Device: Sage Guard oral protection device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oral trauma in intubated patients
The occurrence of oral injuries, including injury to the tongue, lips, cheeks, gums, or other oral tissues, during the period of endotracheal intubation. The incidence of oral trauma will be compared between patients managed with the study device and those receiving standard care.
Measured: Daily assessment up to Day 21
Incidence of endotracheal tube displacement in intubated patients
The occurrence of endotracheal tube movement from its intended position during the period of intubation. The incidence of tube displacement will be compared between patients managed with the study device and those receiving standard care.
Measured: Daily assessment up to Day 21
Incidence of endotracheal tube damage in intubated patients
The occurrence of endotracheal tube damage during the period of intubation. The incidence of tube damage will be compared between patients managed with the study device and those receiving standard care.
Measured: Daily assessment up to Day 21
Secondary outcomes (2)
Frequency of movement of study device position during endotracheal intubation
The occurrence of movement of the study device from its intended position during the period of endotracheal intubation. The frequency of device displacement events will be recorded.
Measured: Daily assessment up to Day 21
Likert Scale Scores of study device use by bedside nursing staff
Feasibility will be assessed by nursing staff using a standardized questionnaire evaluating ease of device placement, maintenance, removal, and integration into routine patient care workflow. A Likert scale is scored by assigning numbers to each answer choice. You then add up or average these numbers to turn soft feelings into hard data. A standard five-point scale gives a score of 1 to 5 for each question - Higher totals mean more of that trait or feeling.
Measured: Daily assessment up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startAug 2027 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Why it stopped: Funding constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubated PatientsStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Obsolete Engineering Co.
- Responsible party
- Sponsor
- Investigators
- Amir Taha, DDS, Study chair, Obsolete Engineering Co.Jesus A. Valdez, DDS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806812
- Sponsor's protocol ID
- IRB00149615
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. Due to the small sample size in this pilot feasibility study, sharing de-identified participant-level data could increase the risk of participant re-identification and compromise confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study to Evaluate the Efficacy, Safety, and Usability of the Sage Guard for Protecting the Vital Structures of the Oral Cavity
- ClinicalTrials.gov ID
- NCT07806812
- Acronym / sponsor ID
- IRB00149615
- Conditions
- Intubated Patients
- Keywords
- endotracheal tube damage and clearance, Intensive care unit intubated patients, Intensive care unit oral trauma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Obsolete Engineering Co.
- Study start
- Aug 2027 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 8 Sep 2026 (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 study will evaluate how safe the device is and how easy it is for healthcare providers to use in patients receiving care in the Intensive Care Unit (ICU).
Detailed description
A device will be placed in participants that are intubated in the ICU. The device will remain in place for up to 21 days, removal of the device will coincide with extubation. Surveys will be completed by experienced healthcare providers in the ICU to answer work related questions and provide a baseline for oral trauma in the ICU while intubated. Bedside nurses will be asked to answer questions about their experience with the device during participant use to understand ease of usability and integration into the workflow.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sage Guard Intervention | Experimental | Device: Sage Guard oral protection deviceParticipants will wear the Sage Guard device during the study procedure to evaluate its feasibility, safety, usability, and effectiveness in protecting vital structures of the oral cavity. |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated ICU patients on mechanical ventilation
- 2 sets of opposing teeth that occlude on both left and right sides
- Attending physician requested a dental evaluation as part of the patient's care
Key exclusion criteria (4 listed)
- Active oral infection or trauma preventing safe device placement
- Known allergy to thermoplastic polyurethane (TPU)
- Severe facial or jaw trauma incompatible with device placement
- Mixed dentition, primary dentition, and edentulous patients
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 |
|---|---|---|
| Sage Guard oral protection deviceThe study device is a single-use mouth device made of a soft plastic material (thermoplastic polyurethane). It has side bite blocks that help keep the teeth apart, a center support that helps hold the breathing tube in place, and tongue guards that help protect the tongue from injury. The device is designed for use in patients with an endotracheal (breathing) tube to help prevent injury to the mouth and tongue caused by biting and to help keep the breathing tube stable. | Device | Sage Guard Intervention |
Primary outcome
Incidence of oral trauma in intubated patients
Time frame: Daily assessment up to Day 21
The occurrence of oral injuries, including injury to the tongue, lips, cheeks, gums, or other oral tissues, during the period of endotracheal intubation. The incidence of oral trauma will be compared between patients managed with the study device and those receiving standard care.
Incidence of endotracheal tube displacement in intubated patients
Time frame: Daily assessment up to Day 21
The occurrence of endotracheal tube movement from its intended position during the period of intubation. The incidence of tube displacement will be compared between patients managed with the study device and those receiving standard care.
Incidence of endotracheal tube damage in intubated patients
Time frame: Daily assessment up to Day 21
The occurrence of endotracheal tube damage during the period of intubation. The incidence of tube damage will be compared between patients managed with the study device and those receiving standard care.
2 secondary outcomes
Frequency of movement of study device position during endotracheal intubation
Time frame: Daily assessment up to Day 21
Likert Scale Scores of study device use by bedside nursing staff
Time frame: Daily assessment up to Day 21
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. Due to the small sample size in this pilot feasibility study, sharing de-identified participant-level data could increase the risk of participant re-identification and compromise confidentiality.
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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. This study is not recruiting at the moment.
Amir Taha, DDS study chair
Obsolete Engineering Co.
Jesus A. Valdez, DDS principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Sage Guard oral protection device in people with Intubated Patients, run by Wake Forest University Health Sciences.
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 4 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: withdrawn, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oral trauma in intubated patients (time frame: Daily assessment up to Day 21). The study lists 3 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 28 Sep 2026.