Rectum CancerCoBot2NCT05652361
Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery
A study testing Additional visualisation of surgical assistance during surgery in people with Rectum Cancer, run by Technische Universität Dresden at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- Additional visualisation of surgical assistance during surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 25 Feb 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with rectal cancer scheduled for robot-assisted rectal resection
- Intact preoperative urogenital/rectal function
- Full capability of consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Visceral, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden, Saxony, 01307
Marius Distler, Prof. Dr., marius.distler@ukdd.de
About this study
Official title: Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study
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
- Rectum Cancer
- Being tested
- Additional visualisation of surgical assistance during surgery
- Keywords
- Robotic Surgery, Total mesorectal excision
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Additional visualisation of surgical assistance during surgery | Experimental | Not described Receives: Other: Additional visualisation of surgical assistance during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours after Surgery
Secondary outcomes (11)
Operating time [min]
Time from skin incision until placement of last skin staple/suture
Measured: During Surgery
Duration of postoperative hospital stay [days]
Postoperative day 1 until day of discharge
Measured: At day of discharge, assessed up to 5 days
Duration of postoperative intermediate/intensive care unit stay [days]
Postoperative day 1 until day of discharge
Measured: At day of discharge, assessed up to 5 days
Frequency of peri-operative morbidity after resection
Frequency of peri-operative complications after surgery until Day of Discharge
Measured: At day of discharge, assessed of up to 5 days
Kind of peri-operative morbidity after resection
Kind of peri-operative complications after surgery until day of discharge
Measured: At day of discharge, assessed of up to 5 days
Assessment of the circumferential resection margin (CRM)
Rate of R0 resections
Measured: At day of discharge, assessed up to 5 days
Number of resected lymphnodes
Number of lymphnodes resected during surgery
Measured: During surgery
Assessment of pelvic function before and after rectal resection
Rectal function will be assessed preoperatively and 12-15 months postoperatively using the standard LARS score questionnaire, resulting in a score between 0 and 42. Higher scores mean a worse outcome (worse pelvic function).
Measured: 15 months
Rectal sphincter function before and after rectal resection
Sphincter function will be assessed by manometry preoperatively and 12 - 15 months postoperatively
Measured: 15 months
Assessment of the difficulty of the preparation
Surgeon questionnaire, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Measured: 48 hours after surgery
Assessment of usability of guidance system
One-time final survey of all participating surgeons, the questionnaire qualitatively assesses nine items, each item scoring from "not at all" to "very much", evaluated individually
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start25 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Marius Distler, Prof. Dr., Principal investigator, University Hospital Carl Gustav Carus Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652361
- Sponsor's protocol ID
- TUD-COBOT2-087
- Other IDs
- DE-25-00015527
- Acronym
- CoBot2
- Status last verified
- Aug 2026
- First submitted
- 7 Dec 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Machine Learning-based Surgical Guidance System for Robot-assisted Rectal Surgery - a First-in-human Interventional Study
- ClinicalTrials.gov ID
- NCT05652361
- Acronym / sponsor ID
- CoBot2 / TUD-COBOT2-087
- Conditions
- Rectum Cancer
- Keywords
- Robotic Surgery, Total mesorectal excision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional visualisation of surgical assistance during surgery | Experimental | Other: Additional visualisation of surgical assistance during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with rectal cancer scheduled for robot-assisted rectal resection
- Intact preoperative urogenital/rectal function
- Full capability of consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional visualisation of surgical assistance during surgeryRobot-assisted anterior rectal resection using daVinci® system as CE-marked gold standard with additional visualization of surgical assistance functions based on machine learning techniques | Other | Additional visualisation of surgical assistance during surgery |
Primary outcome
Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system
Time frame: 72 hours after Surgery
System discrepancy score quantifying major misspecifications of the CoBot system in comparison to the surgeon's action
11 secondary outcomes
Operating time [min]
Time frame: During Surgery
Duration of postoperative hospital stay [days]
Time frame: At day of discharge, assessed up to 5 days
Duration of postoperative intermediate/intensive care unit stay [days]
Time frame: At day of discharge, assessed up to 5 days
Frequency of peri-operative morbidity after resection
Time frame: At day of discharge, assessed of up to 5 days
Kind of peri-operative morbidity after resection
Time frame: At day of discharge, assessed of up to 5 days
Assessment of the circumferential resection margin (CRM)
Time frame: At day of discharge, assessed up to 5 days
Number of resected lymphnodes
Time frame: During surgery
Assessment of pelvic function before and after rectal resection
Time frame: 15 months
Rectal sphincter function before and after rectal resection
Time frame: 15 months
Assessment of the difficulty of the preparation
Time frame: 48 hours after surgery
Assessment of usability of guidance system
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marius Distler, Prof. Dr. principal investigator
University Hospital Carl Gustav Carus Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional visualisation of surgical assistance during surgery in people with Rectum Cancer, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marius Distler, Prof. Dr. (+49 351 458 4098, marius.distler@ukdd.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of discrepancies between the surgeon's preparation and the prediction of the CoBot system (time frame: 72 hours after Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.