Performance
Primary
· Intraoperative
Performance defined as the conversion to an open approach required to complete the procedure
| Group | Value | 95% CI |
|---|---|---|
| TORS | 0 |
Last reviewed · How we verify
NCT03049280
Prospective, Multicenter da Vinci® SP™ Surgical System TORS Study
Completed
NA
Results posted
Last updated 6 October 2020
What this trial tests
NA trial testing Transoral robotic surgery in Oropharyngeal Cancer in 33 participants. Completed in 26 December 2017.
Timeline
17 April 2017
Primary endpoint
14 November 2017
14 November 2017
26 December 2017
Quick facts
| Lead sponsor | Intuitive Surgical |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 17 April 2017 |
| Primary completion | 14 November 2017 |
| Estimated completion | 26 December 2017 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Transoral robotic surgery
Conditions studied
- Oropharyngeal Cancer — all drugs for Oropharyngeal Cancer →
Sponsor
Intuitive Surgical — full company profile →
Who can join
18 and older, any sex, with Oropharyngeal Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Subjects With Device-related Serious Adverse Events
Primary
· Intraoperative period
Safety is determined by measuring the number of subjects that experience device-related serious adverse events
| Group | Value | 95% CI |
|---|---|---|
| TORS | 0 |
Positive Surgical Margin
Secondary
· Through14-days postoperatively
Rate of final positive surgical margins confirmed by pathology
| Group | Value | 95% CI |
|---|---|---|
| TORS | 1 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected during the conduct of the study and through 7 weeks follow-up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
TORS
Serious: 4/33 (12%)
Deaths: 0/33
Serious adverse events (5 terms)
| Reaction | System | TORS |
|---|---|---|
| Hypoxemia | General disorders | — |
| Left middle cerebral artery (MCA) stroke | Vascular disorders | — |
| Hemorrhage | Blood and lymphatic system disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| clostridium difficile enterocolitis | Gastrointestinal disorders | — |
Other adverse events (4 terms — click to expand)
| Reaction | System | TORS |
|---|---|---|
| Neck seroma | Skin and subcutaneous tissue disorders | — |
| Nasal regurgitation | General disorders | — |
| Fall | Social circumstances | — |
| Trismus | General disorders | — |
Most-reported serious reactions: Hypoxemia, Left middle cerebral artery (MCA) stroke, Hemorrhage, Pneumonia, clostridium difficile enterocolitis.
Data from ClinicalTrials.gov NCT03049280 adverse events section.
Sponsor's own description
A prospective, multicenter investigation of the da Vinci® SP™ Surgical System in Transoral Robotic Surgery (TORS) procedures for malignant oropharyngeal tumors.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials.
Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, et al · · 2019 · cited 29× · PMID 31536129 · DOI 10.1001/jamaoto.2019.2654
Verify or expand the search:
- PubMed search for NCT03049280
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Oropharyngeal Cancer
Currently open trials in the same condition.
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- NCT06747390 — Intratumoral Lidocaine Injection Before Oropharyngeal Cancer Surgery · Phase 1 · recruiting
- NCT05363709 — BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients · Phase 2 · active not recruiting
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Other Intuitive Surgical trials
Trials by the same sponsor.
- NCT07346066 — IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery · Phase 3 · not yet recruiting
- NCT07259759 — JURA Study - Observational First-in-human Feasibility Study · completed
- NCT06434727 — Evaluating Intuitive 3D Models in Preoperative Surgical Planning for Thoracic and Colorectal Procedures. · completed
- NCT06308120 — A Trial to Compare Robotic Assisted Bronchoscopy Ion's Clinical Utility for Peripheral Lung Nodule Access and Diagnosis · NA · active not recruiting
- NCT05954767 — IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03049280 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Intuitive Surgical
- Last refreshed: 6 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03049280.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing