NCT05652361

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Feb 2026

Typical duration 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 Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

December 7, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
3.1 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

December 7, 2022

Last Update Submit

February 2, 2026

Conditions

Rectum Cancer

Keywords

Robotic SurgeryTotal mesorectal excision

Outcome Measures

Primary Outcomes (1)

  • Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system

    System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action

    72 hours after Surgery

Secondary Outcomes (11)

  • Operating time [min]

    During Surgery

  • Duration of postoperative hospital stay [days]

    At day of discharge, assessed up to 5 days

  • Duration of postoperative intermediate/intensive care unit stay [days]

    At day of discharge, assessed up to 5 days

  • Frequency of peri-operative morbidity after resection

    At day of discharge, assessed of up to 5 days

  • Kind of peri-operative morbidity after resection

    At day of discharge, assessed of up to 5 days

  • +6 more secondary outcomes

Study Arms (1)

Additional visualisation of surgical assistance during surgery

EXPERIMENTAL
Other: Additional visualisation of surgical assistance during surgery

Interventions

Additional visualisation of surgical assistance during surgeryOTHER

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

Additional visualisation of surgical assistance during surgery

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Marius Distler, Prof. Dr.

    University Hospital Carl Gustav Carus Dresden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marius Distler, Prof. Dr.

CONTACT

+49 351 458 4098marius.distler@ukdd.de

Fiona Kolbinger, Dr.

CONTACT

+49 351 458 4098fiona.kolbinger@ukdd.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2022

First Posted

December 15, 2022

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)