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

February 2, 2026 updated by: University Hospital Tuebingen

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of surgical smoke gas
Time Frame: At the end of the study (9 months)
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

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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