- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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:
- 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.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intraoperative CT imaging
|
Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy
Time Frame: Collected at the time of surgery
|
Collected at the time of surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joseph A Paydarfar, MD, Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D14189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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