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

Inclusion Criteria3

  • Patients with rectal cancer scheduled for robot-assisted rectal resection
  • Intact preoperative urogenital/rectal function
  • Full capability of consent

Exclusion Criteria6

  • Previous/Second malignant disease \<5 years before diagnosis of rectal cancer
  • Previous abdominal surgery, except for laparoscopic appendectomy, laparoscopic cholecystectomy or Cesarean section
  • Pregnant or breastfeeding women
  • Addiction or illness that prevent the person concerned from assessing the nature and scope of the clinical trial and its possible consequences
  • indication that the participant is unlikely to comply with the trial protocoll (e.g. lack of compliance)
  • official or court order for involuntary hospitalization

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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