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

N/ANot Yet RecruitingNCT07632638

Instituto do Cancer do Estado de São Paulo40 enrolled

Overview

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, 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.

The RonovoTM is a novel robotic surgical platform developed for minimally invasive surgery. CONSTELAR is designed as a first-in-clinical-use registry to systematically collect safety, technical performance, and short-term clinical outcome data. Eligible participants are adults (≥18 years) with confirmed malignancy diagnoses scheduled for elective robotic surgery using the RonovoTM system. Exclusion criteria include formal contraindications to minimally invasive surgery, severe prohibitive comorbidities, refusal to consent, or emergency surgery. Data collection spans from preoperative screening through 90-day follow-up, capturing demographics, comorbidities, oncological staging (TNM 8th edition), operative details (docking, console, and anesthesia times), intraoperative events, postoperative complications, adverse events, device technical failures, and oncological surgical outcomes. Adverse events are classified using CTCAE v5.0 and causality assessment relative to the RonovoTM device. The study follows ANVISA RDC 837/2023 regulatory requirements

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Interventions

RonovoTM Robotic Surgical PlatformDEVICE

The RonovoTM is a robotic surgical platform used to perform minimally invasive oncological surgical procedures. The surgeon operates from a console controlling robotic arms with endoscopic instruments. The platform is used for the complete surgical procedure from docking through console operation to undocking.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

30-day postoperative complication rate (Clavien-Dindo classification)

Proportion of participants experiencing any postoperative complication within 30 days of surgery, graded according to the Clavien-Dindo classification system (Grades I-V).

Time frame: 30 days after surgery

Intraoperative conversion rate

Proportion of procedures requiring conversion from robotic approach to conventional laparoscopy or open surgery (laparotomy).