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OpenTrials
Completed

NCT Number: NCT02405000

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

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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Key information

Conditions

Oropharyngeal Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraoperative CT imaging

Other

Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure

Primary outcomes

  1. Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy

    Time frame: Collected at the time of surgery

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2015
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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