Electrosurgical Intervention Analysis: Comparing Procedure Patterns
Electrical Fingerprint: Comparison of Characteristic Patterns of Different Surgical Interventions Based on Electrosurgical Unit Data
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Bernhard Krämer, Prof. Dr.
- Phone Number: +497071-2982211
- Email: Bernhard.kraemer@med.uni-tuebingen.de
Study Locations
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Tübingen, Germany, 72076
- Recruiting
- University Hospital Tuebingen
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Contact:
- Bernhard Krämer, Prof. Dr.
- Phone Number: +497071-29 82211
- Email: Bernhard.kraemer@med.uni-tuebingen.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Procedure type
Procedures:
Data will be collected among patients who undergo surgery at the Department of Women's Health independently of this study. |
• Patients undergoing one of the following surgeries:
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Unknown
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Identification of Unique Electrosurgical Data Patterns ("Digital Fingerprints") for Surgical Procedures
Time Frame: During surgery and post-procedure analysis (data collection over 12 months)
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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:
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During surgery and post-procedure analysis (data collection over 12 months)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bernhard Krämer, Prof. Dr., University Hospital Tuebingen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MT_ERBE Data Logger
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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