Pilot Study of the Sage Guard for Oral Cavity Protection
Part of paid clinical trials in Charlotte, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT07806812
- Status
- Not Yet Recruiting
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Conditions
- Intubated Patients
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sage Guard oral protection device — 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.
Study Details
During placement of a breathing tube, a soft device will be placed in the mouth to help keep the teeth apart and hold the tongue out of the way. This device is designed to help protect the mouth and throat from injury caused by biting, which can lead to swelling or infection. It may also help keep the breathing tube in place and prevent damage to the tube from being bitten. 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).
Key Dates
- First listed
- Sep 8, 2026
- Start date
- Sep 30, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2027
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- Experimental: Sage Guard InterventionParticipants 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.
Primary Outcome Measure
Incidence of oral trauma in intubated patients [ Time Frame: Daily assessment up to Day 21 ]
Central Contacts
- Jesus A. Valdez, DDS704-355-4841
- Amir Taha, DDS
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Atrium Health - Carolinas Medical Center | Charlotte | North Carolina | 28203 | Jesus A Valdez, DDS (PRINCIPAL_INVESTIGATOR) |