RetracTOR/ Retractor for Image Guided Trans-Oral Surgery
ConditionOral Cavity Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRyan J. Halter
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
Undergoing staging endoscopy at DHMC
Ability to understand and the willingness to sign a written informed consent document.
Age ≥ 18 years old
Disqualifiers
Prisoners
Adults with impaired decision-making capacity
Any condition for which, in the opinion of the investigator, contraindicates study participation.
Procedures that use high temperature generating devices such as laser
Trial population
Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: custom device- radiolucent retractor
Trial outcomes
Primary outcomes
1
Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors.
Assessment of intraoperative surgical working volume (SWV) during stereoendoscopy using standard-of-care metal retractor as compared to the same assessment parameters using 3D-printed polymer retractor during stereoendoscopy. Assessments will also include intraoperative SWV with CT-imaging taken with 3D-printed polymer retractor.
Time frame
2024-2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ryan J. Halter
Lead sponsor
Dartmouth-Hitchcock Medical Center
Sponsor institution
Dartmouth College
Collaborator
Source ClinicalTrials.gov