Status:
RECRUITING
Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01473784
Start Date
December 3 2007
End Date
December 31 2025
Last Update
November 3 2025
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210