Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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

NCT ID: NCT01473784Sponsor: Ohio State University Comprehensive Cancer CenterLast updated: 2026-02-10

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

Detailed description

To conduct a pilot single-arm study to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.

Arms & interventions

  • Proceduretransoral robotic surgery

    Undergo TORS using the Da Vinci Robotic Surgical System

  • Procedurequality of life assessment

    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.

Outcome measures

Primary

  • Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions.

    Time frame: up to eight years

Secondary

  • Assess the impact of TORS on the intra-operative surgical outcomes such as operative time, blood loss and complications.

    Time frame: up to eight years

  • Assess the quality of life of the patients with TORS.

    Time frame: up to eight years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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) Exclusion Criteria: * Unexplained fever and/or untreated, active infection * Patient pregnancy * Previous head and neck surgery that would preclude transoral/robotic procedures. This is at the investigator's discretion. This is not an exclusion criterion for the non-surgical arm. * The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches * Inability to grant informed consent * INTRAOPERATIVE EXCLUSION CRITERIA: * Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally

Study locations (1)

Ohio State University Medical Center

Columbus, Ohio, 43210

Recruiting
Enver Ozer, MD · Contact
614-293-8074enver.ozer@osumc.edu
Enver Ozer · Principal Investigator