Abdominal SurgeryIDEMONSTRATENCT05268432
Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
An observational study of Abdominal Surgery, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The aim of the planned study is the development of surgical assistance functions on the basis of clinical routine data and the evaluation of the technical feasibility of an intraoperative demonstration and visualization of such assistance functions in visceral surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Surgery with intraoperative imaging
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 19 May 2021to 31 Dec 2050
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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
Study population: This study will enroll patients undergoing surgery using a laparoscopic or open surgical camera, a surgical robot (e.g. DaVinci®), or intraoperative imaging technology (e.g. ultrasound, CT).
Who may be able to join
- Indication for surgery using a laparoscopic or open surgical camera, a surgical robot (e.g., DaVinci system), or an intraoperative imaging modality (e.g. sonography, intraoperative CT)
- Patient understands German
Who cannot join
- Lack of ability to consent
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 Gastrointestinal-, Thoracic and Vascular Surgery University Hospital Carl Gustav Carus Technische Universität Dresden
Dresden, Saxony, 01307
Marius Distler, Prof. Dr., +49 351 458 18264, marius.distler@ukdd.de
Fiona Kolbinger, Dr. med.
About this study
The aim of the planned study is the development of surgical assistance functions on the basis of clinical routine data and the evaluation of the technical feasibility of an intraoperative demonstration and visualization of such assistance functions in visceral surgery. Furthermore, this trial aims to provide preliminary data on the clinical outcome of such assistance systems.
Read the detailed description
The aim of the clinical trial is to create the conditions for the comprehensive scientific use of new technologies such as augmented and virtual reality, computer-aided navigation and robotics in surgery in order to use these technologies in the future for improved surgical therapy for the benefit of the patient and to support the treating surgical team. The IDEMONSTRATE study is divided into two study parts: the development of a surgical assistance function based on routinely collected clinical (image) data that displays the position of anatomical structures (e.g. blood vessels, organs, tumors) in real time and the technical evaluation of this assistance system in the clinical environment.
For the development of the surgical assistance function, data routinely collected as part of surgical inpatient treatment will be used. For research purposes (and explicitly not to prepare for approval as a medical device), a surgical assistance function is to be developed from this that displays the position of anatomical structures in real time during visceral surgical interventions. This system will then be evaluated in the second part of the study with regard to its technical feasibility and medical relevance.
For the evaluation of the developed assistance function in the context of clinical treatment, the patients and the staff involved will be informed separately. All patients who are eligible for inclusion in the evaluating part of the study are fully capable of giving their consent. All doctors who will take part in the evaluation of the developed algorithm in a clinical context are specialists in general or visceral surgery; these doctors are informed in detail about the risks and sources of error in the context of the application before the developed algorithm and the associated assistance function is used. The evaluation of the developed assistance function takes place exclusively in the context of planned interventions, not in emergency situations.
- Conditions
- Abdominal Surgery
- Being tested
- Surgery with intraoperative imaging
- Keywords
- Surgical data science, computer vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with intraoperative imagingProcedure or surgery
laparoscopic, robot-assisted or other intraoperative imaging (ultrasound, CT, MRI)
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative technical errors of the applied assistance system
Major technical errors: system crash, calculation latency > 1 second, Image distortions
Measured: during surgery
Secondary outcomes (8)
Evaluation of surgical skills
The IDEMONSTRATE skill assessment scale v1.0 will be used to rate surgical skill on a scale from 1 to 5, with higher scores indicating higher skill levels.
Measured: during surgery
Display accuracy of guidance functions
The IDEMONSTRATE display accuracy scale v1.0 will be used to rate display accuracy on a scale from 1 to 5, with higher scores indicating better display accuracy.
Measured: during surgery
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 90 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 90 days
Frequency of peri-operative morbidity after resection
Frequency of peri-operative complications after surgery
Measured: At day of discharge, assessed up to 90 days
Kind of peri-operative morbidity after resection
Kind of peri-operative complications after surgery
Measured: At day of discharge, assessed up to 90 days
Assessment of usability of guidance system
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start19 May 2021
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marius Distler, Prof. Dr., Principal investigator, Technische Universität Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268432
- Sponsor's protocol ID
- VTG-09
- Acronym
- IDEMONSTRATE
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2022
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Following publication of study results, de-identified patient data may be made available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
- ClinicalTrials.gov ID
- NCT05268432
- Acronym / sponsor ID
- IDEMONSTRATE / VTG-09
- Conditions
- Abdominal Surgery
- Keywords
- Surgical data science, computer vision
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 7 Mar 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 planned study is the development of surgical assistance functions on the basis of clinical routine data and the evaluation of the technical feasibility of an intraoperative demonstration and visualization of such assistance functions in visceral surgery. Furthermore, this trial aims to provide preliminary data on the clinical outcome of such assistance systems.
Detailed description
The aim of the clinical trial is to create the conditions for the comprehensive scientific use of new technologies such as augmented and virtual reality, computer-aided navigation and robotics in surgery in order to use these technologies in the future for improved surgical therapy for the benefit of the patient and to support the treating surgical team. The IDEMONSTRATE study is divided into two study parts: the development of a surgical assistance function based on routinely collected clinical (image) data that displays the position of anatomical structures (e.g. blood vessels, organs, tumors) in real time and the technical evaluation of this assistance system in the clinical environment.
For the development of the surgical assistance function, data routinely collected as part of surgical inpatient treatment will be used. For research purposes (and explicitly not to prepare for approval as a medical device), a surgical assistance function is to be developed from this that displays the position of anatomical structures in real time during visceral surgical interventions. This system will then be evaluated in the second part of the study with regard to its technical feasibility and medical relevance.
For the evaluation of the developed assistance function in the context of clinical treatment, the patients and the staff involved will be informed separately. All patients who are eligible for inclusion in the evaluating part of the study are fully capable of giving their consent. All doctors who will take part in the evaluation of the developed algorithm in a clinical context are specialists in general or visceral surgery; these doctors are informed in detail about the risks and sources of error in the context of the application before the developed algorithm and the associated assistance function is used. The evaluation of the developed assistance function takes place exclusively in the context of planned interventions, not in emergency situations.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll patients undergoing surgery using a laparoscopic or open surgical camera, a surgical robot (e.g. DaVinci®), or intraoperative imaging technology (e.g. ultrasound, CT).
Key inclusion criteria (2 listed)
- Indication for surgery using a laparoscopic or open surgical camera, a surgical robot (e.g., DaVinci system), or an intraoperative imaging modality (e.g. sonography, intraoperative CT)
- Patient understands German
Key exclusion criteria (1 listed)
- Lack of ability to consent
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 |
|---|---|---|
| Surgery with intraoperative imaginglaparoscopic, robot-assisted or other intraoperative imaging (ultrasound, CT, MRI) | Procedure or surgery | – |
Primary outcome
Incidence of intraoperative technical errors of the applied assistance system
Time frame: during surgery
Major technical errors: system crash, calculation latency > 1 second, Image distortions
8 secondary outcomes
Evaluation of surgical skills
Time frame: during surgery
Display accuracy of guidance functions
Time frame: during surgery
Operating time [min]
Time frame: during surgery
Duration of postoperative hospital stay [days]
Time frame: At day of discharge, assessed up to 90 days
Duration of postoperative intermediate/intensive care unit stay [days]
Time frame: At day of discharge, assessed up to 90 days
Frequency of peri-operative morbidity after resection
Time frame: At day of discharge, assessed up to 90 days
Kind of peri-operative morbidity after resection
Time frame: At day of discharge, assessed up to 90 days
Assessment of usability of guidance system
Time frame: 48 hours after surgery
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 10 Feb 2026.
- Individual participant dataSharing planned: No. Following publication of study results, de-identified patient data may be made available upon reasonable request
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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
Technische Universität Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Surgery, 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 2 inclusion and 1 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 10 Feb 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 351045818264, 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 intraoperative technical errors of the applied assistance system (time frame: during 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 10 Feb 2026.