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NCT06112535
Prospective Clinical Study to Assess the Safety and Efficacy of Versius, in Transoral Robotic Surgery
NA trial testing Versius Surgical System in Squamous Cell Carcinoma of the Oropharynx in 60 participants. Completed in 22 April 2025.
16 April 2025
Quick facts
| Lead sponsor | CMR Surgical Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 13 December 2023 |
| Primary completion | 16 April 2025 |
| Estimated completion | 22 April 2025 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Versius Surgical System
Conditions studied
- Squamous Cell Carcinoma of the Oropharynx — all drugs for Squamous Cell Carcinoma of the Oropharynx →
- Squamous Cell Carcinoma, Unknown Primary — all drugs for Squamous Cell Carcinoma, Unknown Primary →
Sponsor
CMR Surgical Ltd
Who can join
18 and older, any sex, with Squamous Cell Carcinoma of the Oropharynx or Squamous Cell Carcinoma, Unknown Primary. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-arm, single site, multi-surgeon prospective feasibility study for transoral robot assisted surgery (TORS) with the Versius Surgical System. Versius is a robotic system designed to help in the accurate control of surgical instruments for minimal access ("keyhole") surgery. In TORS procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. The primary objective of this study will be to evaluate the safe use and performance of the Versius in transoral surgeries. Pre-clinical work has been conducted to ensure TORS with Versius is viable and safe; this will be one of the first in-human studies of TORS with Versius. This study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. The safety of Versius for TORS will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of TORS cases successfully completed with Versius (i.e. without having to switch to another surgical technique).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06112535
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Versius Surgical System
Trials testing the same drug.
- NCT06539442 — Versius Paediatrics Study · NA · recruiting
- NCT07537556 — Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost- · active not recruiting
Other recruiting trials for Squamous Cell Carcinoma of the Oropharynx
Currently open trials in the same condition.
- NCT05962242 — HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma · Phase 2 · recruiting
- NCT06061705 — Identification of Individual Histological and Blood Markers in Patients With Recurrent or Metastatic Upper Aerodigestive · NA · recruiting
- NCT05918510 — Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus · recruiting
- NCT04104945 — p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT) · NA · recruiting
- NCT04151134 — Evaluation of Tongue Base MucOsectomy & Step sErial Sectioning · active not recruiting
Other CMR Surgical Ltd trials
Trials by the same sponsor.
- NCT06539442 — Versius Paediatrics Study · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06112535 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CMR Surgical Ltd
- Last refreshed: 25 June 2025
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/NCT06112535.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing