NCT07632638

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

June 19, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 2, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

June 2, 2026

Last Update Submit

July 1, 2026

Conditions

CancerMalignant Neoplasms

Keywords

Robotic surgeryMinimally invasive surgeryOncological surgery

Outcome Measures

Primary Outcomes (3)

  • 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).

    30 days after surgery

  • Intraoperative conversion rate

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

    Intraoperative (day of surgery)

  • Device-related technical failure rate

    Proportion of procedures in which a device technical failure occurred (hardware, software, camera/vision, connectivity, or power failure) and its clinical impact.

    Intraoperative (day of surgery)

Secondary Outcomes (7)

  • Total operative time

    Intraoperative (day of surgery)

  • Robot docking time

    Intraoperative (day of surgery)

  • Robotic console time

    Intraoperative (day of surgery)

  • Estimated blood loss

    Intraoperative (day of surgery)

  • Length of hospital stay

    Up to 90 days after surgery

  • +2 more secondary outcomes

Study Arms (1)

RonovoTM Robotic Surgery

EXPERIMENTAL

All enrolled participants undergo elective oncological surgery using the RonovoTM robotic surgical platform.

Device: RonovoTM Robotic Surgical Platform

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.

RonovoTM Robotic Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Confirmed malignancy diagnosis
  • Elective indication for robotic approach using RonovoTM
  • Able to understand and sign informed consent

You may not qualify if:

  • Formal contraindication to minimally invasive surgery
  • Severe comorbidity prohibiting the procedure
  • Refusal to participate or sign informed consent
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, São Paulo, 05403-010, Brazil

RECRUITING

Related Publications (3)

  • Nandy 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: 38818004BACKGROUND

  • Liu 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: 39966128BACKGROUND

  • Pokhrel 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: 40221629BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ulysses MD, PhD Ribeiro Jr

    Instituto do Câncer do Estados de São Paulo (ICESP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulysses Ribeiro Júnior, Principal Investigator, MD, Ph

CONTACT

+55 11 3893-3515icesp.pesquisa.np@hc.fm.usp.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A Prospective, Single-Arm, Multi-Specialty Registry.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start

June 19, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 2, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

It has been decided not to share Individual Participant Data (IPD) related to the study for several reasons.Protecting the privacy of participants is a priority. Sharing IPD may expose sensitive information that, even when de-identified, can be traced back to individuals. Furthermore, the complexity of the data makes sharing challenging without the risk of misunderstandings or misinterpretations, which could compromise the integrity of the research. Sharing IPD without the explicit consent of participants may violate ethical principles of respect and protection. There is also a need to comply with regulatory guidelines governing data sharing to avoid potential legal issues. Finally, the focus will be on disseminating aggregated results that can benefit the scientific community and the public without compromising individual privacy.

Locations

BR(1)