RecruitingNCT06873347

Electrosurgical Intervention Analysis: Comparing Procedure Patterns

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


Sponsor

University Hospital Tuebingen

Enrollment

160 participants

Start Date

Feb 21, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

  • 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 Criteria4

  • 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

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Interventions

DEVICEProcedure 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

DEVICE

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


Locations(1)

University Hospital Tuebingen

Tübingen, Germany

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NCT06873347


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