Clinical trial · Interventional
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
NCT05652361CI-TRIAL-00124110CoBot2recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional visualisation of surgical assistance during surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Additional visualisation of surgical assistance during surgery
- interventionNames
- Other: Additional visualisation of surgical assistance during surgery
Primary outcomes (1)
- measure
- Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
- timeFrame
- 72 hours after Surgery
- description
- System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action
Secondary outcomes (11)
- measure
- Operating time [min]
- timeFrame
- During Surgery
- description
- Time from skin incision until placement of last skin staple/suture
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with rectal cancer scheduled for robot-assisted rectal resection * Intact preoperative urogenital/rectal function * Full capability of consent Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.