Clinical trial NCT06873347: Electrosurgical Intervention Analysis: Comparing Procedure Patterns
Official title: Electrical Fingerprint: Comparison of Characteristic Patterns of Different Surgical Interventions Based on Electrosurgical Unit Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Electrosurgical Data Recording
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Erbe Elektromedizin GmbH
First posted: 2025-03-12
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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 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".

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Identification of Unique Electrosurgical Data Patterns ("Digital Fingerprints") for Surgical Procedures
timeFrame: During surgery and post-procedure analysis (data collection over 12 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Bernhard Krämer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: