Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-10-24

Brief Summary

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The objective of this research is to perform a pilot study on patients undergoing laryngoscopy for diagnostic and tumor staging purposes (for pharyngeal or laryngeal cancer) in which intraoperative CT imaging will be performed both prior to (but after induction of general endotracheal anesthesia) and during placement of the laryngoscope in order to better understand anatomic changes that occur during instrumentation of the oral cavity and oropharynx. The goals of the study are:

1. Develop a suite of de-identified images and surface renderings that qualitatively show how a tumor and the upper aerodigestive tract anatomy deform during a laryngoscopic evaluation.
2. Create deformation models of the upper aerodigestive tract.

This data to be used for future retractor development as well as for virtual image guided surgery.

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Detailed Description

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Conditions

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Oropharyngeal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intraoperative CT imaging

Group Type EXPERIMENTAL

Intraoperative CT imaging

Intervention Type OTHER

Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure

Interventions

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Intraoperative CT imaging

Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients (\>18 years) seen in the Head and Neck Tumor Clinic who will require laryngoscopy in the operating room for diagnosis and staging of known or suspected tumors of the upper aerodigestive tract.

Exclusion Criteria

* Patients who are unable to tolerate general anesthesia.
* Patients who are felt to be a "difficult airway" for induction of general endotracheal anesthesia.
* Patients with excessive dental restorations and amalgam.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No