Detection of Surgical Smoke Gas Using AINCT07397000
AI-Based Real-Time Detection of Surgical Smoke Using Endoscopic Data
An observational study of Detection of Surgical Smoke Gas Using AI, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Detection of Surgical Smoke Gas Using AI
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 21 Feb 2024to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- - Age ≥ 18 years
- Written consent after receiving information
- Indication for surgical treatment using HF surgery
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Women's Health, University Hospital
Tübingen
Prof. Dr. Bernhard Krämer, +497071 2982211, bernhard.kraemer@med.uni-tuebingen.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Detection of Surgical Smoke Gas Using AI
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of surgical smoke gas
Detection of surgical smoke gas with an accuracy of an F1 score of ≥ 0.8 on test data sets.
Measured: At the end of the study (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start21 Feb 2024
- Primary completion26 May 2025
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detection of Surgical Smoke Gas Using AIStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Bernhard Krämer, Principal investigator, Deparment of Women's Health, University Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397000
- Sponsor's protocol ID
- MT_STORZ Rauchgasabsaugung
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of AI-Based Approaches for Automated Real-Time Detection of Surgical Smoke Using Endoscopic Image and Video Data
- ClinicalTrials.gov ID
- NCT07397000
- Acronym / sponsor ID
- MT_STORZ Rauchgasabsaugung
- Conditions
- Detection of Surgical Smoke Gas Using AI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- - Age ≥ 18 years
- Written consent after receiving information
- Indication for surgical treatment using HF surgery
Key exclusion criteria (3 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Bernhard Krämer principal investigator
Deparment of Women's Health, University Hospital Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Detection of Surgical Smoke Gas Using AI, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Bernhard Krämer (+497071 2982211, bernhard.kraemer@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of surgical smoke gas (time frame: At the end of the study (9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.