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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02405000
Enrollment
23
Registered
2015-04-01
Start date
2015-04-30
Completion date
2017-10-24
Last updated
2021-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Cancer

Brief summary

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.

Interventions

OTHERIntraoperative CT imaging

Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Radiographic evidence of upper aerodigestive tract deformation during laryngoscopyCollected at the time of surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026