RetracTOR 3D-printed polymer retractor for trans-oral surgery

In Vivo Evaluation of a CT-Compatible Retractor for Image Guided Trans-Oral Surgery

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
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Dartmouth-Hitchcock Medical Center (Academic / other)
• Locations: 1 site (Lebanon, New Hampshire)
• Trial ID: NCT06381505 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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

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Where this trial is running

Lebanon, New Hampshire

• 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

Conditions Oral Cavity Disease; retractor