Electrosurgical Intervention Analysis: Comparing Procedure Patterns

NCT06873347 | Recruiting

• 1 other identifier: MT_ERBE Data Logger
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Procedure, Unspecified

Outcome Measures

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.

  During surgery and post-procedure analysis (data collection over 12 months)

Study Arms (2)

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.

Device: Procedure type

Unknown

Interventions

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

Procedure type

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Erbe Elektromedizin GmbH: collaborator

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

RECRUITING

Study Officials

• Bernhard Krämer, Prof. Dr.

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Krämer, Prof. Dr.

CONTACT

+497071-2982211; Bernhard.kraemer@med.uni-tuebingen.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: March 12, 2025
• Study Start: February 21, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

DE (1)