Surgical Procedure, UnspecifiedNCT06873347
Electrosurgical Intervention Analysis: Comparing Procedure Patterns
An observational study of Surgical Procedure, Unspecified, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this prospective, single center study is to verify the hypothesis that each type of intervention creates a specific data pattern like a digital "fingerprint". This fingerprint offers the possibility to identify specific workflows of surgical procedures but also to differentiate between them, what can be… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Procedure type
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- 21 Feb 2024to Jun 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted as a single-center study with patient recruitment among patients who visit the Department of Women's Health. No patients must be recruited only for the purpose of this study. Data will be collected among patients who undergo surgery at the Department of Women's Health independently of this study. The prospective, single center study is designed as a pilot study. A case number estimate is not possible. The aim is to include a total of about 160 patients in the pilot study. Procedure Number of cases Supra cervical hysterectomy 40 Total hysterectomy 40 B-plastic + periareolar mastopexy 40 Segmental resection 40
Who may be able to join
- Age ≥ 18 years
- Written informed consent
- Patients undergoing one of the following surgeries:
- Supra cervical hysterectomy
- Total hysterectomy
- Breast conserving surgeries: B-plastic + periareolar mastopexy
- Breast conserving surgeries: segmental resection
Who cannot join
- Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial
- Lack of patient consent
- Surgery under local anaesthesia
- Robot-Assisted Surgery
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
University Hospital Tuebingen
Tübingen, 72076
Bernhard Krämer, Prof. Dr., +497071-29 82211, Bernhard.kraemer@med.uni-tuebingen.de
About this study
Official title: Electrical Fingerprint: Comparison of Characteristic Patterns of Different Surgical Interventions Based on Electrosurgical Unit Data
The purpose of this prospective, single center study is to verify the hypothesis that each type of intervention creates a specific data pattern like a digital "fingerprint". This fingerprint offers the possibility to identify specific workflows of surgical procedures but also to differentiate between them, what can be used for training purposes. The following clinical study is not covered by the MDR regulation since we do not investigate performance or safety of a device but collect and assign electrical data only.
Read the detailed description
The Erbe ESU VIO 3 provides electrical measurement data with high accuracy and time resolution. With the availability of the Erbe ECB Data Transmitter it is possible to record electrical data from the VIO 3 during clinical procedures, which open up a variety of possibilities for enhancing clinical workflows.
For this purpose, the VIO 3 will be connected via ECB (Erbe communication bus) interface with the "Data Transmitter". Using the software implemented by Erbe on the "Data transmitter", electrical data - generated during electrosurgical interventions - are recorded, forwarded via LAN, WLAN or LTE and stored in the Azure Cloud. These data do not contain any patient information and will be only used for the stated study objective.
In future, based on the analyses of electrosurgical device data users could benefit from e.g. continuous training as well as self enhancement/reflection by electrosurgical information offered during or after a surgical procedure. A first step to reach this goal is to build up a database containing electrosurgical data of different surgical interventions, to identify the electrosurgical "fingerprint" of each intervention and to detect different patterns between them. Therefore, the purpose of this study is to record electrosurgical data and to verify the hypothesis that each type of intervention creates a specific data pattern like a digital "fingerprint".
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Procedure type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure typeDevice
- Patients undergoing one of the following surgeries:
- Supra cervical hysterectomy
- Total hysterectomy
- Breast conserving surgeries: B-plastic + periareolar mastopexy
- Breast conserving surgeries: segmental resection
Device
- A dataset from procedure types other than the above mentioned to the type "unknown" is assigned to this type.
| Study group | Role | What they receive |
|---|---|---|
| Procedure type | Procedures:
* Supra cervical hysterectomy (+/- salpingectomy)
* Total hysterectomy
* Breast conserving surgeries: b-plastic + periareolar mastopexy (+/- Sentinel lymphonodectomy, SLNE)
* Breast conserving surgeries: segmental resection (+/- SLNE)
Data will be collected among patients who undergo surgery at the Department of Women's Health independently of this study. Receives: Device: Procedure type | |
| Unknown | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Unique Electrosurgical Data Patterns ("Digital Fingerprints") for Surgical Procedures
The study aims to determine whether different types of surgical interventions generate distinct electrosurgical data patterns. The accuracy of assigning recorded electrosurgical data to the correct surgical procedure type will be evaluated.
Data Source: Electrosurgical signals recorded by the Erbe ECB Data Transmitter and VIO 3 system, stored in the Erbe Cloud for analysis.
Measurement Method:
- Each dataset will be classified into one of the predefined procedure types or as "unknown."
- The classification algorithm must achieve at least 80% accuracy in correctly identifying procedure types.
- The classification algorithm must achieve at least 80% accuracy in assigning procedures outside the predefined types to the "unknown" category.
Measured: During surgery and post-procedure analysis (data collection over 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start21 Feb 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Responsible party
- Sponsor
- Investigators
- Bernhard Krämer, Prof. Dr., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873347
- Sponsor's protocol ID
- MT_ERBE Data Logger
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Fingerprint: Comparison of Characteristic Patterns of Different Surgical Interventions Based on Electrosurgical Unit Data
- ClinicalTrials.gov ID
- NCT06873347
- Acronym / sponsor ID
- MT_ERBE Data Logger
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Erbe Elektromedizin GmbH
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 12 Mar 2025 (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 purpose of this prospective, single center study is to verify the hypothesis that each type of intervention creates a specific data pattern like a digital "fingerprint". This fingerprint offers the possibility to identify specific workflows of surgical procedures but also to differentiate between them, what can be used for training purposes. The following clinical study is not covered by the MDR regulation since we do not investigate performance or safety of a device but collect and assign electrical data only.
Detailed description
The Erbe ESU VIO 3 provides electrical measurement data with high accuracy and time resolution. With the availability of the Erbe ECB Data Transmitter it is possible to record electrical data from the VIO 3 during clinical procedures, which open up a variety of possibilities for enhancing clinical workflows.
For this purpose, the VIO 3 will be connected via ECB (Erbe communication bus) interface with the "Data Transmitter". Using the software implemented by Erbe on the "Data transmitter", electrical data - generated during electrosurgical interventions - are recorded, forwarded via LAN, WLAN or LTE and stored in the Azure Cloud. These data do not contain any patient information and will be only used for the stated study objective.
In future, based on the analyses of electrosurgical device data users could benefit from e.g. continuous training as well as self enhancement/reflection by electrosurgical information offered during or after a surgical procedure. A first step to reach this goal is to build up a database containing electrosurgical data of different surgical interventions, to identify the electrosurgical "fingerprint" of each intervention and to detect different patterns between them. Therefore, the purpose of this study is to record electrosurgical data and to verify the hypothesis that each type of intervention creates a specific data pattern like a digital "fingerprint".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedure type | – | Device: Procedure typeProcedures: * Supra cervical hysterectomy (+/- salpingectomy) * Total hysterectomy * Breast conserving surgeries: b-plastic + periareolar mastopexy (+/- Sentinel lymphonodectomy, SLNE) * Breast conserving surgeries: segmental resection (+/- SLNE) Data will be collected among patients who undergo surgery at the Department of Women's Health independently of this study. |
| Unknown | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted as a single-center study with patient recruitment among patients who visit the Department of Women's Health. No patients must be recruited only for the purpose of this study. Data will be collected among patients who undergo surgery at the Department of Women's Health independently of this study. The prospective, single center study is designed as a pilot study. A case number estimate is not possible. The aim is to include a total of about 160 patients in the pilot study. Procedure Number of cases Supra cervical hysterectomy 40 Total hysterectomy 40 B-plastic + periareolar mastopexy 40 Segmental resection 40
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Written informed consent
- Patients undergoing one of the following surgeries:
Key exclusion criteria (4 listed)
- Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial
- Lack of patient consent
- Surgery under local anaesthesia
- Robot-Assisted Surgery
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 |
|---|---|---|
| Procedure type• Patients undergoing one of the following surgeries: * Supra cervical hysterectomy * Total hysterectomy * Breast conserving surgeries: B-plastic + periareolar mastopexy * Breast conserving surgeries: segmental resection | Device | Procedure type |
| • A dataset from procedure types other than the above mentioned to the type "unknown" is assigned to this type. | Device | Unknown |
Primary outcome
Identification of Unique Electrosurgical Data Patterns ("Digital Fingerprints") for Surgical Procedures
Time frame: During surgery and post-procedure analysis (data collection over 12 months)
The study aims to determine whether different types of surgical interventions generate distinct electrosurgical data patterns. The accuracy of assigning recorded electrosurgical data to the correct surgical procedure type will be evaluated. Data Source: Electrosurgical signals recorded by the Erbe ECB Data Transmitter and VIO 3 system, stored in the Erbe Cloud for analysis. Measurement Method: * Each dataset will be classified into one of the predefined procedure types or as "unknown." * The classification algorithm must achieve at least 80% accuracy in correctly identifying procedure types. * The classification algorithm must achieve at least 80% accuracy in assigning procedures outside the predefined types to the "unknown" category.
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 26 Jan 2026.
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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.
Bernhard Krämer, Prof. Dr. principal investigator
University Hospital Tuebingen
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 Surgical Procedure, Unspecified, run by University Hospital Tuebingen 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 7 inclusion and 4 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 26 Jan 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 Bernhard Krämer, Prof. Dr. (+497071-2982211, Bernhard.kraemer@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Unique Electrosurgical Data Patterns ("Digital Fingerprints") for Surgical Procedures (time frame: During surgery and post-procedure analysis (data collection over 12 months)). 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 26 Jan 2026.