AI-Based Real-Time Detection of Surgical Smoke Using Endoscopic Data

Development of AI-Based Approaches for Automated Real-Time Detection of Surgical Smoke Using Endoscopic Image and Video Data

The goal of this observational, prospective monocentric pilot study is to generate a pilot dataset to train a computer-assisted model for automatic, intraoperative detection of surgical smoke gas.

Women with indications for laparoscopic evaluation requiring the use of HF surgery (expecting the formation of smoke gas) and a smoke evacuation system (Karl Storz S-Pilot) are employed.

Study Overview

• Status: Recruiting
• Conditions: Detection of Surgical Smoke Gas Using AI

Detailed Description

Detection of surgical smoke gas with an accuracy F1 score of >= 0.8 on test datasets. The activation of the S-Pilot by clinic personnel will be used as the gold standard.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Prof. Dr. Bernhard Krämer; Phone Number: +497071 2982211; Email: bernhard.kraemer@med.uni-tuebingen.de

Study Locations

• Germany
  • Tübingen, Germany
    • Recruiting
    • Department of Women's Health, University Hospital
    • Contact: Prof. Dr. Bernhard Krämer; Phone Number: +497071 2982211; Email: bernhard.kraemer@med.uni-tuebingen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 years or older undergoing laparoscopic gynecological procedures at the Department of Women's Health, University Hospital Tübingen, where high-frequency surgical technology (monopolar, bipolar, or ultrasound) is used and surgical smoke generation is expected. All procedures will utilize the KARL STORZ S-Pilot smoke evacuation system.

Description

Inclusion Criteria:

• - Age ≥ 18 years
• Written consent after receiving information
• Indication for surgical treatment using HF surgery

Exclusion Criteria:

• - Expected lack of compliance by the patient or inability of the patient to understand the meaning and purpose of the clinical trial
• Lack of patient consent
• S-Pilot cannot be used

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of surgical smoke gas	Detection of surgical smoke gas with an accuracy of an F1 score of ≥ 0.8 on test data sets.	At the end of the study (9 months)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen
• Investigators: Principal Investigator: Prof. Dr. Bernhard Krämer, Deparment of Women's Health, University Hospital Tübingen

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Actual): May 26, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MT_STORZ Rauchgasabsaugung

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No