A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System

Who is this study for? Adult patients with Oral Cavity or Laryngopharynx Benign and/or Malignant Diseases that have prior trans-oral exposure
What treatments are being studied? Trans-Oral Robotic Surgery
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)

• Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

• Written informed consent and/or Consent waiver by institutional review board (IRB)

Locations
United States
Ohio
Ohio State University Medical Center
RECRUITING
Columbus
Contact Information
Primary
Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
1-800-293-5066
Backup
Chelsea Marra
Chelseaanne.Marra@osumc.edu
Time Frame
Start Date: 2007-12-03
Estimated Completion Date: 2025-09-10
Participants
Target number of participants: 600
Treatments
Experimental: Transoral robotic surgery (TORS)
Patients will undergo TORS for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System. After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov