Clinical trial · Interventional
Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
A Prospective, Multicenter Investigation of the da Vinci® SP™ Surgical System in TORS Procedures for Resection of Malignant Tumors
NCT03049280CI-TRIAL-00047511completedN/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)
A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
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 |
|---|---|---|---|
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transoral robotic surgery | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transoral robotic surgery
- interventionNames
- Device: Transoral robotic surgery
Primary outcomes (2)
- measure
- Performance
- timeFrame
- Intraoperative
- description
- Performance defined as the conversion to an open approach required to complete the procedure
- measure
- Number of Subjects With Device-related Serious Adverse Events
- timeFrame
- Intraoperative period
- description
- Safety is determined by measuring the number of subjects that experience device-related serious adverse events
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years or older * T1 or T2 malignant oropharyngeal tumor * Tumor amenable to transoral resection * No previous treatment for the index tumor * Willing and able to provide written informed consent * Willing and able to comply with the study protocol requirements Exclusion Criteria: * T3 or T4 stage tumor * Previous radiation treatment to the head and neck, with or without chemotherapy * Evidence of other primary cancers or distant metastasis or subject with synchronous primary tumor excluding skin cancers * Pre-operative expectation of needing microvascular soft-tissue reconstruction * Tumor that invades and/or abuts the internal and/or external carotid artery * Retropharyngeal carotid artery coincident with a tonsillar cancer or posterior pharyngeal wall cancer * Evidence of mandibular invasion of tumor * Eastern Cooperative Oncology Group Performance Status score greater than or equal to 2 * On a medication that interferes with clotting that cannot be stopped prior to surgery * Contraindication for general anesthesia or surgery * Mentally handicapped or has psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent * Pregnant or suspected to be pregnant
References
Publications (1)
- DERIVEDHolsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654. PMID 31536129