An observational study in Oral Cavity Disease, sponsored by Ryan J. Halter. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Ryan J. Halter · Observational
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.
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 vs. our 3D printed retractor. Patients to be recruited for the study will include those who present to the Head and Neck Tumor Clinic at Dartmouth-Hitchcock Medical Center (DHMC) with suspicious lesions identified in the oropharynx, hypopharynx or larynx. Currently the clinic sees about 20 patients per month that are scheduled for staging endoscopy in the operating room. Consent will be obtained from all participating subjects prior to participation.
All surgeries will be performed at the Center for Surgical Innovation. Prior to surgery a standard-of-care Feyh-Kastenbauer (FK) or Crowe-Davis (CD) metal retractor will be positioned in the mouth of the patient and stabilized in suspension. A standard-of-care stereo vision endoscope will capture images of the oral cavity so that a 3D volume of the surgical working volume (SWV) can be measured. The time to place the retractor and surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance (IID) will be recorded. The FK and/or CD retractor will then be removed and replaced with our custom 3d-printed radiolucent retractor. The time to place this retractor and surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance will be recorded. A single CT scan with IV contrast will be obtained with the retractor in place and suspended. The standard surgical procedure will commence following routine methods. Following surgery, a second set of surgical working volume metrics based on stereovision derived oral-cavity volumes and inter-incisive distance will be recorded.
99 studies on the registry are indexed under Mouth Diseases; 19 are open to participants now.
This study's planned enrollment of 20 is below the median of 128 across 37 observational studies indexed under Mouth Diseases.
Browse Mouth Diseases studies →Ryan J. Halter is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Procedures that use high temperature generating devices such as laser
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Custom device-radiolucent retractor used during staging endoscopy.
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: 2024-2025
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Dec 2027, 34 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ryan J. Halter