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CompletedNCT06873373Updated Jan 29, 2026

AI Based Real Time Detection of Endometriosis Lesions

An observational study in Endometriosis, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
Female
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Study summary

Development of AI-based approaches for automated real-time detection of endometriosis lesions using endoscopic image and video material.

Read the detailed description

In the field of endometriosis, artificial intelligence (AI) has been used for diagnoses or even predictions of endometriosis before confirmation through laparoscopy. AI's significant potential in minimally invasive surgery lies in automatic image analysis, aiding in the detection of structures or anomalies based on image data. This offers the potential to detect endometriosis lesions during laparoscopy regardless of the indication. Training and creating such AI models are done using machine learning algorithms based on annotated data. These training data consist of image data with pixel-level annotations of the content that the model should detect. Deep learning (DL) algorithms have proven effective in image analysis, relying on neural networks to autonomously fill them with the most critical decision criteria for correct analysis of the image content. The trained AI model can then be applied to unknown data, providing the probability of detecting a structure for each pixel. Possible visual outputs of the model include outlining the detected content or segmenting, assigning predefined content to each pixel. The quality of the model depends crucially on a sufficiently large number and quality of training data. Quality includes correct annotation of data to prevent the model from learning errors. Diversifying image data by including negative examples in the training and test datasets is equally important. The F1-score is used as a measure of the model's quality, combining precision (P) with recall (R) to a value between 0 and 1, based on an annotated test dataset.

The goal is to achieve a high F1-score through the selection of training data and an appropriate DL algorithm. Parameters like image preparation optimization or DL algorithm parameters such as selecting different neural networks can improve the F1-score. The number of required training data for a good AI model depends on the complexity of the question and the number of contents to be detected, as the model can only recognize learned content. It is possible to iteratively adjust the selection of training data for different questions based on the achieved F1-scores after each training and testing. If necessary, the number of training data can be increased, and problematic image data, such as missing annotations, can be identified and corrected based on the results.

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Conditions studied

  • Endometriosis

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03

In context

Endometriosis

901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.

This study's enrollment of 26 is below the median of 128 across 344 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Included are patients who present themselves at the University Women's Clinic as part of the outpatient clinic in the Endometriosis Center. Women with a suspected diagnosis or confirmed diagnosis of endometriosis who have an indication for laparoscopic assessment are included.

Inclusion criteria

  • Age ≥ 18 years
  • Written consent after explanation
  • Indication for surgical treatment of endometriosis

Exclusion criteria

Exclusion Criteria:

  • Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial
  • Absence of patient consent
  • Malignancies
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • Suspected endometriosis
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What researchers measure

Primary outcomes

  1. Development and validation of an AI model for real-time automated detection of endometriosis lesions

    * Based on laparoscopic image and video data. * Evaluation of model accuracy using the F1-score, with a target value of ≥ 0.7.

    Time frame: During time-span of study (approx. 1 year)

  2. Quality of video anonymization

    * Assessment of the effectiveness of the "InOut" AI model v0.2 in identifying and removing non-relevant image data. * Quality assurance through manual review of anonymized data. The videos are correlated with the following anonymized metadata, which are also transferred to KS * Age group of the patient (18-25; 25-30; 35-40,…) * Weight class of the patient (BMI \<17.5; 17.5-19; \>19-25; \>25-30; \>30) * Type of surgery (laparoscopy with or without treatment of endometriosis) * Total duration of the operation * Complications during the operation (yes/no) * Endoscopic devices used, especially the camera * Existing pathological findings related to endometriosis

    Time frame: During time-span of study (approx. 1 year)

  3. Creation of a high-quality annotated image dataset for AI training

    * Target: 80-90% of selected images should contain endometriosis lesions, with the remaining being negative samples. * Annotation performed by medical professionals Clinically trained personnel at the University Hospital Tübingen (UKT) select 300 varied JPEG images from each anonymized video for annotation. The aim is to include 80%-90% of images displaying endometriosis lesions, with the remainder depicting other tissue abnormalities or no lesions.

    Time frame: During time-span of study (approx. 1 year)

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Study locations

1 site
  • University Hospital Tuebingen, Department of Women's Health
    Tübingen, 72076, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06873373
Lead sponsor
University Hospital Tuebingen
Responsible party
Sponsor
First posted
Mar 12, 2025
Start date
Oct 10, 2023
Primary completion
Jan 28, 2025
Completion
Jun 30, 2025
Last update
Jan 29, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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