Recruiting

Transoral Robotic Surgery

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT01473784

Conditions

Recurrent Adenoid Cystic Carcinoma of the Oral Cavity

Recurrent Mucoepidermoid Carcinoma of the Oral Cavity

Recurrent Squamous Cell Carcinoma of the Hypopharynx

Recurrent Squamous Cell Carcinoma of the Larynx

Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

transoral robotic surgery

quality of life assessment

Study Details

Brief 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

Conditions

Recurrent Adenoid Cystic Carcinoma of the Oral Cavity

Recurrent Mucoepidermoid Carcinoma of the Oral Cavity

Recurrent Squamous Cell Carcinoma of the Hypopharynx

Recurrent Squamous Cell Carcinoma of the Larynx

Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity

Study ID

NCT01473784

Start date

Dec 3, 2007

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

transoral robotic surgery

Undergo TORS using the Da Vinci Robotic Surgical System

quality 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.

Primary outcome measure

  • Determine the feasibility of the TORS in patients with oral and laryngopharyngeal benign and malignant lesions. [ Time Frame: up to eight years ]

Central Contacts and Locations

Central contacts

Ohio State University Comprehensive Cancer Center

1-800-293-5066OSUCCCClinicaltrials@osumc.edu

Chelsea Marra

Chelseaanne.Marra@osumc.edu

Locations

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Enver Ozer, MD

614-293-8074enver.ozer@osumc.edu

Principal Investigator:

Enver Ozer

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Feb 10, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-02-10.