Recruitment

Recruitment Status
Recruiting

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)
Written informed consent and/or Consent waiver by institutional review board (IRB)
Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
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)
Written informed consent and/or Consent waiver by institutional review board (IRB)
Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

Exclusion Criteria

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.
Patient pregnancy
The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
...
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.
Patient pregnancy
The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
Inability to grant informed consent
INTRAOPERATIVE EXCLUSION CRITERIA:
Unexplained fever and/or untreated, active infection

Summary

Conditions
  • Recurrent Squamous Cell Carcinoma of the Hypopharynx
  • Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage III Mucoepidermoid Carcinoma of the Oral Cavity
  • Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Larynx
  • Stage IVA Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage II Verrucous Carcinoma of the Oral Cavity
  • Stage III Verrucous Carcinoma of the Larynx
  • Stage IVA Verrucous Carcinoma of the Oral Cavity
  • Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IV Squamous Cell Carcinoma of the Hypopharynx
  • Stage IVB Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Tongue Cancer
  • Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage III Verrucous Carcinoma of the Oral Cavity
  • Stage II Squamous Cell Carcinoma of the Larynx
  • Stage IVB Verrucous Carcinoma of the Larynx
  • Stage IVC Squamous Cell Carcinoma of the Larynx
  • Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage IVB Squamous Cell Carcinoma of the Larynx
  • Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Recurrent Verrucous Carcinoma of the Larynx
  • Stage IVB Verrucous Carcinoma of the Oral Cavity
  • Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage I Verrucous Carcinoma of the Larynx
  • Stage III Squamous Cell Carcinoma of the Larynx
  • Stage I Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage II Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage II Squamous Cell Carcinoma of the Hypopharynx
  • Stage III Squamous Cell Carcinoma of the Hypopharynx
  • Stage I Squamous Cell Carcinoma of the Larynx
  • Recurrent Verrucous Carcinoma of the Oral Cavity
  • Stage 0 Hypopharyngeal Cancer
  • Stage 0 Laryngeal Cancer
  • Stage I Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage II Verrucous Carcinoma of the Larynx
  • Stage IVA Squamous Cell Carcinoma of the Larynx
  • Stage IVC Verrucous Carcinoma of the Oral Cavity
  • Stage IVC Verrucous Carcinoma of the Larynx
  • Stage 0 Lip and Oral Cavity Cancer
  • Stage IVA Verrucous Carcinoma of the Larynx
  • Stage IVC Mucoepidermoid Carcinoma of the Oral Cavity
  • Stage I Verrucous Carcinoma of the Oral Cavity
  • Stage I Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
  • Stage II Mucoepidermoid Carcinoma of the Oral Cavity
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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.

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.

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)
Written informed consent and/or Consent waiver by institutional review board (IRB)
Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation
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)
Written informed consent and/or Consent waiver by institutional review board (IRB)
Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation

Exclusion Criteria

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.
Patient pregnancy
The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
...
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.
Patient pregnancy
The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
Inability to grant informed consent
INTRAOPERATIVE EXCLUSION CRITERIA:
Unexplained fever and/or untreated, active infection

Locations

Columbus, Ohio, 43210
Columbus, Ohio, 43210

Tracking Information

NCT #
NCT01473784
Collaborators
Not Provided
Investigators
  • Principal Investigator: Enver Ozer, MD Ohio State University
  • Enver Ozer, MD Ohio State University