RetracTOR 3D-printed polymer retractor for trans-oral surgery
Official title: In Vivo Evaluation of a CT-Compatible Retractor for Image Guided Trans-Oral Surgery
Run by Dartmouth-Hitchcock Medical Center · NCT06381505 · Data updated 2026-11-12
This study will test whether a 3D-printed polymer mouth retractor holds the mouth open as well as a standard metal retractor during endoscopy and throat surgery for adults with suspected lesions of the oral cavity, oropharynx, hypopharynx, or larynx.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 7, 2026 |
| Trial ID | NCT06381505 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) who can give informed consent and are undergoing staging endoscopy at Dartmouth-Hitchcock for suspected or confirmed lesions of the oral cavity, oropharynx, hypopharynx, or larynx and meet routine pregnancy and safety criteria.
✕Probably not a fit
Patients who cannot consent, are prisoners, have impaired decision-making capacity, require procedures using high-temperature devices such as lasers, or whose anatomy necessitates a metal retractor may not receive benefit from the polymer device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study compares surgical exposure within the same patient using a standard-of-care metal retractor versus a 3D-printed polymer retractor during staging endoscopy for suspected head and neck lesions. Investigators will collect subject history, measure intraoperative surgical working volume (SWV) with stereoendoscopy using the metal retractor, repeat SWV measurements with the polymer retractor, and obtain a CT-based SWV assessment with the polymer device. All procedures and imaging are performed at the Center for Surgical Innovation at Dartmouth-Hitchcock Medical Center, and consented patients scheduled for staging endoscopy will be enrolled. The protocol builds on benchtop data showing comparable mechanical performance and seeks to demonstrate comparable in vivo exposure and imaging metrics.
Why it matters
Potential benefit: If successful, the polymer retractor could provide equivalent mouth opening while offering a lighter, customizable, and potentially lower-cost non-metal option that may improve imaging and workflow.
How similar studies have gone: Benchtop experiments have shown similar mechanical function between metal and polymer retractors, but clinical in-patient comparisons are limited and this application is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 \-
Where it's running
-
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States Recruiting
Study contacts
- Principal investigator: Ryan J Halter, PhD — Dartmouth-Hitchcock, Lebanon
- Study coordinator: Ryan J Halter, PhD
- Email: Ryan.J.Halter@dartmouth.edu
- Phone: 603 646-0773
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.