RetracTOR/ Retractor for Image Guided Trans-Oral Surgery

NCT06381505 | Not Yet Recruiting

• 1 other identifier: STUDY02002103
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

retractor

Outcome Measures

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.

  2024-2025

Study Arms (1)

custom device- radiolucent retractor

Custom device-radiolucent retractor used during staging endoscopy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.

You may qualify if:

• 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
• For females of child bearing potential, a negative pregnancy evaluation per standard of care.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ryan J. Halter: lead
• Dartmouth College: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

• Ryan J Halter, PhD

  Dartmouth-Hitchcock, Lebanon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan J Halter, PhD

CONTACT

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

Kathy J Phipps, BA

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator and Regulatory Sponsor

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 24, 2024
• Study Start: May 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)