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

Study acronym: CONSTELAR
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Primary completion date changed from estimate of Sep 2026 to Aug 29, 2026
    • Eligibility criteria expanded, about 8 words
    • Site details revised
    • Publications: details revised at 3 of 3 entries
  2. Recruitment opened
    • Start date changed from estimate of Jun 2026 to Jun 19, 2026
    • Site details revised
    v3
  3. Study description expanded, about 20 words
    • Site contact updated
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07632638
Lead Sponsor Instituto do Cancer do Estado de São Paulo
Collaborators: Ronovo (Shanghai) Medical Science and Technology Ltd
Conditions
(from sponsor)		 Malignant Neoplasms, Cancer
Related terms Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov