In Vivo Evaluation of a CT-Compatible Retractor for Image Guided Trans-Oral Surgery
Ryan J. Halter
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.
Description
This study will include four stages of data collection: 1) Subject history, 2) intraoperative surgical working volume (SWV) assessment with stereoendoscopy and standard-of-care metal retractor, 3) intraoperative surgical working volume assessment with stereoendoscopy and 3D-printed polymer retractor, 4) intraoperative surgical working volume assessment with CT-imaging and 3D-printed polymer retractor. The investigators will conduct a comparative study examining differences in surgical exposure within the same patient when retraction is enabled through use of standard-of-care metal retractor v…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 te…
Location
- Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire