Recruiting

Retractor Comparison

Sponsor:

Ryan J. Halter

Code:

NCT06381505

Conditions

Oral Cavity Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Oral Cavity Disease

Study ID

NCT06381505

Start date

Feb 25, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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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Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

custom device- radiolucent retractor

Custom device-radiolucent retractor used during staging endoscopy.

Primary outcome measure

  • Comparing intraoperative surgical working volume (SWV) of a radiolucent retractor (custom device) as compared to SWV of standard-of-care metal retractors. [ Time Frame: 2024-2025 ]

Central Contacts and Locations

Central contacts

Ryan J Halter, PhD

603 646-0773Ryan.J.Halter@dartmouth.edu

Kathy J Phipps, BA

603 646-5793kathy.j.phipps@dartmouth.edu

Locations

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Joseph Paydarfar, MD

603-650-8123joseph.a.paydarfar@hitchcock.org

More Information

Sponsor

Ryan J. Halter

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • retractor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ryan J. Halter on 2026-04-07.