Trials / Unknown
UnknownNCT05022368
Oral Device Clinical Trial
Surgical Safety Device Use During Transoral Surgery
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- Nationwide Children's Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The investigators are studying the use of a new medical device developed at Nationwide Children's. This technology has been licensed and produced by Zotarix LLC, a medical device company. It is designed to aid in retraction and provide protection of the lips during surgery. The investigators are not recording any of your identifiable personal health information except for the surgery date. This device, called the LabraGuard is a sterile, soft medical grade silicone, and no alternative device with these exact protective properties exists, and the investigators are trying to learn more about how it performs in different age children.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LabraGuard | Protection of the lips and the oral commissure during transoral procedures |
Timeline
- Start date
- 2021-05-24
- Primary completion
- 2022-08-01
- Completion
- 2024-08-01
- First posted
- 2021-08-26
- Last updated
- 2023-09-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05022368. Inclusion in this directory is not an endorsement.