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Safety and Performance Evaluation of the RonovoTM Robotic Surgical Platform in Oncological Procedures

RECRUITINGN/ASponsored by Instituto do Cancer do Estado de São Paulo
Actively Recruiting
PhaseN/A
SponsorInstituto do Cancer do Estado de São Paulo
Started2026-06-19
Est. completion2026-09
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07632638

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerMalignant Neoplasms

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