Incisional HerniaBIO-HERN-IANCT07898449
Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
An observational study of Incisional Hernia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Incisional hernias are defects in the continuity of the abdominal wall that impair its mechanical function. This retrospective, single-center, non-interventional study aims to develop a patient-specific biomechanical model of the abdominal wall using artificial intelligence and finite element analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2026to 14 Apr 2027
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent surgery at the University Hospital of Strasbourg for a midline, lateral, or parastomal incisional hernia during the specified retrospective study period.
Who may be able to join
- Adults aged 18 years or older.
- Patients who underwent surgery at the University Hospital of Strasbourg between January 1, 2018, and September 1, 2026.
- Midline, lateral, or parastomal incisional hernia.
- Prosthetic reinforcement may or may not have been used.
Who cannot join
- Written objection documented in the patient's medical record to the reuse of their data for scientific research.
- Legal protection measure.
- Minor patients.
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de cchirurgie générale & digestive - CHU de Strasbourg, France
Strasbourg, 67091
Benoit Romain, MD, PhD, 33 3.88.12.72.43, benoit.romain@chru-strasbourg.fr
Benoit Romain, MD, PhD
About this study
Incisional hernias are defects in the continuity of the abdominal wall that impair its mechanical function. This retrospective, single-center, non-interventional study aims to develop a patient-specific biomechanical model of the abdominal wall using artificial intelligence and finite element analysis. Anonymized computed tomography (CT) data will be analyzed to automatically identify and quantify key morphological features of the abdominal wall and incisional hernia. These features will be combined with clinical data and previously obtained experimental data on tissue mechanics to create a numerical model tailored to each patient.
- Conditions
- Incisional Hernia
- Keywords
- Incisional Hernia, Artificial intelligence, Finite element analysis, Hernia Morphology
- Medical subject headings
- Incisional Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
Automated Identification and Quantification of Abdominal Wall and Incisional Hernia Morphological Parameters
Identification and automatic quantification, using artificial intelligence, of the main morphological parameters of the abdominal wall and incisional hernia from anonymized CT scans.
Measured: Retrospective data from patients operated on between January 1, 2018, and September 1, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start14 Oct 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion14 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898449
- Sponsor's protocol ID
- RC26_0320
- Acronym
- BIO-HERN-IA
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Specific Biomechanical Modeling of Incisional Hernias Using Artificial Intelligence and Finite Element Analysis
- ClinicalTrials.gov ID
- NCT07898449
- Acronym / sponsor ID
- BIO-HERN-IA / RC26_0320
- Conditions
- Incisional Hernia
- Keywords
- Incisional Hernia, Artificial intelligence, Finite element analysis, Hernia Morphology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 14 Apr 2027 (estimated)
- First posted
- 27 Oct 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.
Incisional hernias are defects in the continuity of the abdominal wall that impair its mechanical function. This retrospective, single-center, non-interventional study aims to develop a patient-specific biomechanical model of the abdominal wall using artificial intelligence and finite element analysis. Anonymized computed tomography (CT) data will be analyzed to automatically identify and quantify key morphological features of the abdominal wall and incisional hernia. These features will be combined with clinical data and previously obtained experimental data on tissue mechanics to create a numerical model tailored to each patient.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent surgery at the University Hospital of Strasbourg for a midline, lateral, or parastomal incisional hernia during the specified retrospective study period.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Patients who underwent surgery at the University Hospital of Strasbourg between January 1, 2018, and September 1, 2026.
- Midline, lateral, or parastomal incisional hernia.
- Prosthetic reinforcement may or may not have been used.
Key exclusion criteria (4 listed)
- Written objection documented in the patient's medical record to the reuse of their data for scientific research.
- Legal protection measure.
- Minor patients.
- Pregnancy.
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
Automated Identification and Quantification of Abdominal Wall and Incisional Hernia Morphological Parameters
Time frame: Retrospective data from patients operated on between January 1, 2018, and September 1, 2026
Identification and automatic quantification, using artificial intelligence, of the main morphological parameters of the abdominal wall and incisional hernia from anonymized CT scans.
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 27 Oct 2026.
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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.
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 Incisional Hernia, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 inclusion and 4 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 27 Oct 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 France. 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 Benoit Romain, MD, PhD (33 3.88.12.72.43, benoit.romain@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Automated Identification and Quantification of Abdominal Wall and Incisional Hernia Morphological Parameters (time frame: Retrospective data from patients operated on between January 1, 2018, and September 1, 2026). 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 27 Oct 2026.