Using robotic surgery to treat tumors in the head and neck

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical trial evaluates the effectiveness of transoral robotic surgery (TORS) for patients with benign or malignant tumors in the oral cavity and laryngopharynx. The study utilizes the Da Vinci Robotic Surgical System to perform less invasive surgical procedures, which may lead to fewer side effects and improved recovery times. Participants will undergo surgery and have their quality of life assessed post-procedure to determine the impact of TORS on their health outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Ohio State University Medical Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: Enver Ozer, MD — Ohio State University
• Study coordinator: Ohio State University Comprehensive Cancer Center
• Email: OSUCCCClinicaltrials@osumc.edu
• Phone: 1-800-293-5066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.