Clinical trial · Interventional
Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Lesions Using Da Vinci Robotic Surgical System
A Pilot Study Assessing Transoral Robotic Surgery (TORS) for Oral and Laryngopharyngeal Benign and Malignant Lesions Using the Da Vinci Robotic Surgical System
NCT01059357CI-TRIAL-00035836TORScompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to conduct a pilot single-arm to assess transoral robotic surgery (TORS) for oral and laryngopharyngeal benign and malignant lesions using the Da Vinci Robotic Surgical System.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Da Vinci Robotic Transoral Robotic Surgical System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transoral Robotic Surgery (TORS)
- description
- Transoral Robotic Surgery (TORS) using the Da Vinci Robotic Surgical System
- interventionNames
- Device: Da Vinci Robotic Transoral Robotic Surgical System
Primary outcomes (1)
- measure
- The Number and Percent of All Evaluable Patients Who Have Successfully Undergone TORS at Each Interim Analysis.
- timeFrame
- At time of surgery, lasting up to 3 hours. Assessed for up to 6 months
- description
- In order to evaluate the feasibility of TORS, the investigators will report the number and percent of all evaluable patients who have successfully undergone TORS at each interim analysis
Secondary outcomes (5)
- measure
- Operative Time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must present with indications for diagnostic or therapeutic approaches for benign and 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 Exclusion Criteria: * Unexplained fever and/or untreated, active infection * Patient pregnancy * Previous head and neck surgery precluding transoral/robotic procedures * The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches
References
Publications (0)
Data not yet available
No reference posted for this study.