Electrosurgical Intervention Analysis: Comparing Procedure Patterns

Официальное название

Electrical Fingerprint: Comparison of Characteristic Patterns of Different Surgical Interventions Based on Electrosurgical Unit Data

Обзор

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.

Подробное описание

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".

Вмешательства

• Устройство 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
• Устройство
  • A dataset from procedure types other than the above mentioned to the type "unknown" is assigned to this type.

Первичные конечные точки

• Identification of Unique Electrosurgical Data Patterns ("Digital Fingerprints") for Surgical Procedures [Срок оценки: During surgery and post-procedure analysis (data collection over 12 months)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Германия · 1 центр

• University Hospital Tuebingen — Tübingen

Идентификаторы

NCT: NCT06873347 · MT_ERBE Data Logger

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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