RecruitingNot ApplicableNCT05652361

Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery

Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study


Sponsor

Technische Universität Dresden

Enrollment

12 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of the study is to evaluate the technical feasibility and applicability of a surgical assistance system based on image recognition algorithms in a first-in-human pilot study. In addition, this study will provide preliminary data on the oncological outcome of the assistance system.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a machine learning-based guidance system for robot-assisted rectal cancer surgery improves safety and accuracy — helping surgeons better identify critical structures like nerves and blood vessels during the procedure. **You may be eligible if...** - You have been diagnosed with rectal cancer and are scheduled for robot-assisted surgery - Your urogenital and rectal functions are intact before surgery - You are able and willing to give consent **You may NOT be eligible if...** - You have had another cancer diagnosis within the last 5 years - You have had major prior abdominal surgeries (other than appendix, gallbladder, or C-section) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAdditional visualisation of surgical assistance during surgery

Robot-assisted anterior rectal resection using daVinci® system as CE-marked gold standard with additional visualization of surgical assistance functions based on machine learning techniques


Locations(1)

Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden

Dresden, Saxony, Germany

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NCT05652361


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