Electrosurgical Intervention Analysis: Comparing Procedure Patterns
ConditionSurgical Procedure, Unspecified
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Written informed consent
Supra cervical hysterectomy
Total hysterectomy
Disqualifiers
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 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
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Procedure type
Device• 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Procedure type1 intervention
Group B: Unknown0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
During surgery and post-procedure analysis (data collection over 12 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Tuebingen
Lead sponsor
Erbe Elektromedizin GmbH
Collaborator
Source ClinicalTrials.gov