Mechanical Intestinal ObstructionSMARTLOOPNCT04795388
Development of an Artificial Intelligence Algorithm
An observational study of Mechanical Intestinal Obstruction, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Mechanical obstruction of the small intestine is an interruption of intestinal transit due to an organic obstacle in the digestive tract that results in a shutdown of materials and gas. Without medical care, it can lead to perforation of the intestinal wall and acute peritonitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Intestinal Obstruction
- How many people
- 589 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with an abdominal scan performed at Saint-Joseph Hospital and diagnosed with mechanical obstruction of the small intestine on a flange or adhesion
Who may be able to join
- Patient whose age is ≥ 18 years
- Patients with an abdominal scan performed at Saint-Joseph Hospital
- Patients diagnosed with mechanical obstruction of the small intestine on a flange or adhesion
- Patients having abdominal surgery within 48 hours of diagnosis or medical follow-up at Saint Joseph Hospital
- French-speaking patient
Who cannot join
- Patients with a history of abdominal surgery one month before diagnosis
- Patients objecting to the use of their data for this research
- Patient under guardianship or curatorship
- Patient under legal protection
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Development of an Artificial Intelligence Algorithm to Identify the Main Risks of Ischemia of Mechanical Intestinal Obstruction
Mechanical obstruction of the small intestine is an interruption of intestinal transit due to an organic obstacle in the digestive tract that results in a shutdown of materials and gas. Without medical care, it can lead to perforation of the intestinal wall and acute peritonitis. It accounts for 4% of emergency department admissions and 20% of emergency surgeries
Read the detailed description
The abdominopelvic tomodensitometric examination is the gold standard for making a diagnosis and identifying the cause, the level of the lesion and looking for signs of severity related to the risk of ischemia of the intestinal tissue. Well characterized, these signs remain difficult to identify for a non-expert radiologist. The evaluation of the detection performance of these signs shows a sensitivity between 63 and 100% and a specificity between 61 and 96% with a great variation according to the signs studied.
Our research project aims to develop a tool for the detection of the three main signs of severity of mechanical intestinal obstruction to raise and standardize the level of detection of the risk of ischemia on abdominal CT images.
- Conditions
- Mechanical Intestinal Obstruction
- Keywords
- ischemia
- Medical subject headings
- Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction
The comparison score (Dice) between manual classifications and locations performed by clinical experts and those automatically predicted by the tool.
Measured: Day 1
Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction
The number of occlusions
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Aug 2020
- Primary completion30 Oct 2021
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Intestinal ObstructionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc ZINS, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795388
- Sponsor's protocol ID
- SMARTLOOP
- Acronym
- SMARTLOOP
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2021
- Last updated
- 27 Apr 2023
- 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 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Artificial Intelligence Algorithm to Identify the Main Risks of Ischemia of Mechanical Intestinal Obstruction
- ClinicalTrials.gov ID
- NCT04795388
- Acronym / sponsor ID
- SMARTLOOP / SMARTLOOP
- Conditions
- Mechanical Intestinal Obstruction
- Keywords
- ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 589 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Mar 2021 (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.
Mechanical obstruction of the small intestine is an interruption of intestinal transit due to an organic obstacle in the digestive tract that results in a shutdown of materials and gas. Without medical care, it can lead to perforation of the intestinal wall and acute peritonitis. It accounts for 4% of emergency department admissions and 20% of emergency surgeries
Detailed description
The abdominopelvic tomodensitometric examination is the gold standard for making a diagnosis and identifying the cause, the level of the lesion and looking for signs of severity related to the risk of ischemia of the intestinal tissue. Well characterized, these signs remain difficult to identify for a non-expert radiologist. The evaluation of the detection performance of these signs shows a sensitivity between 63 and 100% and a specificity between 61 and 96% with a great variation according to the signs studied.
Our research project aims to develop a tool for the detection of the three main signs of severity of mechanical intestinal obstruction to raise and standardize the level of detection of the risk of ischemia on abdominal CT images.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an abdominal scan performed at Saint-Joseph Hospital and diagnosed with mechanical obstruction of the small intestine on a flange or adhesion
Key inclusion criteria (5 listed)
- Patient whose age is ≥ 18 years
- Patients with an abdominal scan performed at Saint-Joseph Hospital
- Patients diagnosed with mechanical obstruction of the small intestine on a flange or adhesion
- Patients having abdominal surgery within 48 hours of diagnosis or medical follow-up at Saint Joseph Hospital
- French-speaking patient
Key exclusion criteria (5 listed)
- Patients with a history of abdominal surgery one month before diagnosis
- Patients objecting to the use of their data for this research
- Patient under guardianship or curatorship
- Patient under legal protection
- Patient deprived of liberty
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
Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction
Time frame: Day 1
The comparison score (Dice) between manual classifications and locations performed by clinical experts and those automatically predicted by the tool.
Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction
Time frame: Day 1
The number of occlusions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
Related trials for Mechanical Intestinal Obstruction
Not yet recruiting
Postbiotics for GI Recovery After Malignant Bowel Obstruction Surgery
Age 18 to 80 Years, Malignant Mechanical Bowel Obstruction Diagnosed Clinically/Radiologically, With Prior Abdominal Surgery for Relief
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. This study is not recruiting at the moment.
Marc ZINS principal investigator
Fondation Hôpital Saint-Joseph
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 Mechanical Intestinal Obstruction, run by Fondation Hôpital Saint-Joseph 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction (time frame: Day 1). The study lists 2 primary outcomes in all. 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 Apr 2023.