Clinical trial · Interventional
Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures
Safety and Technical Evaluation of a Robotic Platform (RonovoTM) in Elective Oncological Surgery: A Prospective, Single-Arm, Multi-Specialty Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
CONSTELAR is a prospective, single-arm, multi-specialty registry designed to evaluate the safety and intraoperative performance of the RonovoTM robotic surgical platform in adult patients undergoing elective oncological surgery. The study enrolls patients across four surgical specialties (Digestive Surgery, Thoracic Surgery, Urology, and Gynecology) at a single academic center. Primary endpoints include 30-day and 90-day complication rates (Clavien-Dindo classification), operative times, conversion rates, estimated blood loss, and device-related technical failures. Secondary endpoints encompass length of hospital stay, Intensive Care Unit (ICU) admission, readmission/reoperation rates, and oncological surgical outcomes (resection margins, lymph node harvest). The study aims to provide initial safety and feasibility data to support the regulatory pathway for the RonovoTM platform in Latin America.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Malignant Neoplasms | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RonovoTM Robotic Surgical Platform | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RonovoTM Robotic Surgery
- description
- All enrolled participants undergo elective oncological surgery using the RonovoTM robotic surgical platform.
- interventionNames
- Device: RonovoTM Robotic Surgical Platform
Primary outcomes (3)
- measure
- 30-day postoperative complication rate (Clavien-Dindo classification)
- timeFrame
- 30 days after surgery
- description
- Proportion of participants experiencing any postoperative complication within 30 days of surgery, graded according to the Clavien-Dindo classification system (Grades I-V).
- measure
- Intraoperative conversion rate
- timeFrame
- Intraoperative (day of surgery)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Confirmed malignancy diagnosis 3. Elective indication for robotic approach using RonovoTM 4. Able to understand and sign informed consent Exclusion Criteria: 1. Formal contraindication to minimally invasive surgery 2. Severe comorbidity prohibiting the procedure 3. Refusal to participate or sign informed consent 4. Emergency surgery
References
Publications (3)
- BACKGROUNDNandy K, Patkar S, Varty G, Shah T, Goel M. Outcomes of Robotic Surgery in a Single-institution, High-volume Hepatobiliary Oncology Unit. Indian J Surg Oncol. 2024 May;15(Suppl 2):289-296. doi: 10.1007/s13193-024-01873-6. Epub 2024 Jan 16. PMID 38818004
- BACKGROUNDLiu Y, Zhao Z, Xu P, Li Y, Chang W, Ji M. Initial experience with the Carina platform in robotic-assisted hysterectomy for gynecological malignant disease. Surg Endosc. 2025 Apr;39(4):2346-2353. doi: 10.1007/s00464-025-11588-6. Epub 2025 Feb 18. PMID 39966128
- BACKGROUNDPokhrel G, Wang Z, Cui J, Jin B, Zheng H, Tao J, Fan Y, Liu Y, Zhan Y, Yu S, Dong B, Zhang X. Initial experience with the novel modular robotic system Carina in urology: a prospective study on safety feasibility and surgical settings. Sci Rep. 2025 Apr 12;15(1):12686. doi: 10.1038/s41598-025-97411-7. PMID 40221629