RetracTOR/ Retractor for Image Guided Trans-Oral Surgery
This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held o
| Condition(s) | Oral Cavity Disease |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This study aims to demonstrate that a polymer retractor functions the same as a standard metal retractor used during endoscopy and throat surgery. The retractor is the device that holds the mouth open so the surgeon can easily access the mouth and throat. For example, this study aims to confirm that the mouth is held open the same amount with a polymer retractor as it is with a metal retractor. Benchtop experiments have demonstrated that the metal and polymer retractor's function the same, and thus this study will use this in patients. |
| Who can participate | Inclusion Criteria: 1. Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection. 2. Undergoing staging endoscopy at DHMC 3. Ability to understand and the willingness to sign a written informed consent document. 4. Age ≥ 18 years old 5. For females of child bearing potential, a negative pregnancy evaluation per standard of care. Exclusion Criteria: 1. Prisoners 2. Adults with impaired decision-making capacity 3. Any condition for which, in the opinion of the investigator, contraindicates study participation. 4. Procedures that use high temperature generating devices such as laser \- |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Ryan J. Halter |
| Locations | Lebanon, New Hampshire, United States |
| Start date | 2025-02-25 |
| NCT ID | NCT06381505 |
| Official listing | https://clinicaltrials.gov/study/NCT06381505 |