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NCT Number: NCT01473784

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

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

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Key information

Conditions

Recurrent Adenoid Cystic Carcinoma of the Oral Cavity Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharyngeal Neoplasms Laryngeal Diseases Laryngeal Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms 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 Recurrent Verrucous Carcinoma of the Larynx Recurrent Verrucous Carcinoma of the Oral Cavity Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Carcinoma of Head and Neck Stage 0 Hypopharyngeal Cancer Stage 0 Laryngeal Cancer Stage 0 Lip and Oral Cavity Cancer Stage I Adenoid Cystic Carcinoma of the Oral Cavity Stage I Mucoepidermoid Carcinoma of the Oral Cavity Stage I Squamous Cell Carcinoma of the Hypopharynx Stage I Squamous Cell Carcinoma of the Larynx Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity Stage I Verrucous Carcinoma of the Larynx Stage I Verrucous Carcinoma of the Oral Cavity Stage II Adenoid Cystic Carcinoma of the Oral Cavity Stage II Mucoepidermoid Carcinoma of the Oral Cavity Stage II Squamous Cell Carcinoma of the Hypopharynx Stage II Squamous Cell Carcinoma of the Larynx Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity Stage II Verrucous Carcinoma of the Larynx Stage II Verrucous Carcinoma of the Oral Cavity Stage III Adenoid Cystic Carcinoma of the Oral Cavity Stage III Mucoepidermoid Carcinoma of the Oral Cavity Stage III Squamous Cell Carcinoma of the Hypopharynx Stage III Squamous Cell Carcinoma of the Larynx Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity Stage III Verrucous Carcinoma of the Larynx Stage III Verrucous Carcinoma of the Oral Cavity Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity Stage IVA Squamous Cell Carcinoma of the Larynx Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVA Verrucous Carcinoma of the Larynx Stage IVA Verrucous Carcinoma of the Oral Cavity Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity Stage IVB Squamous Cell Carcinoma of the Larynx Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVB Verrucous Carcinoma of the Larynx Stage IVB Verrucous Carcinoma of the Oral Cavity Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity Stage IVC Squamous Cell Carcinoma of the Larynx Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVC Verrucous Carcinoma of the Larynx Stage IVC Verrucous Carcinoma of the Oral Cavity Stomatognathic Diseases Tongue Cancer Tongue Diseases Tongue Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Enver Ozer

PRINCIPAL_INVESTIGATOR

Enver Ozer, MD

CONTACT

[email protected]

614-293-8074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transoral Robotic Surgery

Procedure

Undergo TORS using the Da Vinci Robotic Surgical System

Other names: TORS, DA VINCI® ROBOTIC SURGICAL SYSTEM

quality of life assessment

Procedure

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.

Other names: questionnaire

Primary outcomes

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

    Time frame: up to eight years

Secondary outcomes

  1. 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

    If the planned procedure is a combined procedure, (robotic + non robotic) above mentioned measures are going to be presented separately for successful fully robotic surgeries and for unsuccessful mixed surgeries.

    • To identify the learning curve for TORS by measuring the efficiency and accuracy of the surgeons who perform the procedures.

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

    Time frame: up to eight years

Study contacts

Contact information is provided by the study sponsor or research team.

Chelsea Marra

CONTACT

[email protected]

Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

1-800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2026
Study completion
2026
First posted
Nov 17, 2011
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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