Crohn's DiseaseCAPSCDEISNCT00492791
Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy
An observational study of Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 20 sites in 2 countries.
Trial summary
The endoscopic capsule is a new tool for exploration of the small intestine. The superiority of this technique on the radiological conventional examinations was shown in Crohn's disease. However no standardization of the lesions exists and no score of severity was proposed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- wireless endoscopy capsule
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 158 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Mar 2007to Dec 2011
- 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: Active or quiescent Crohn's Disease
Who may be able to join
- Patients older than 18 years.
- Crohn's disease diagnosed on clinical, endoscopic, histological criteria. In active or inactive phase of their disease (HBI > 4; CDAI > 150).
- The patients will belong to the one of the 4 groups defined above according to the examinations carried out during the follow-up of the disease.
- Group 1: at least one ileal ulceration at ileocolonoscopy and no radiological abnormality
- Group 2: nonsevere attack on radiological examinations with or without endoscopic lesion
- Group 3: severe attack on radiological examinations with or without endoscopic lesion.
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- Group 4: no lesion neither in endoscopy nor on radiologic exams.
- Small intestine standard exploration less than 1 year.
- Affiliation with the social security or a mode of social protection.
- able to understand and sign an informed consent.
Who cannot join
- ano-perineal location.
- Occlusion or sub-occlusion chronicle or intermittent or if there are frank signs of dilation of small intestine on the morphological examinations.
- Martial treatment since less than ten days before the realization of the capsule.
- Non steroidal anti-inflammatory treatment since less than three months before the realization of the capsule.
- Ileostomy on hail.
- Pace-maker or another implantable device.
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- Swallowing troubles.
- Non evacuation of the Patency capsule in the 48 hours.
- Occlusion during the passage of the patency capsule.
- pregnant woman.
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
France17 sites
Chu Amiens
Amiens, 80054
Chu Besancon
Besançon, 25030
Hopital Saint Andre
Bordeaux, 33075
CHU CAEN
Caen, 14033
Hopital Beaujon
Clichy, 92110
Chru Lille
Lille, 59037
Chu Nantes
Nantes, 44093
CHU NICE
Nice, 06202
Hopital Lariboisiere
Paris, 75010
Hopital Saint Louis
Paris, 75010
Hopital St Antoine
Paris, 75012
Hopital Georges Pompidou
Paris, 75015
Institut Mutualiste Montsouris (Imm)
Paris, 75674
Chu Rouen
Rouen, 76031
Chu Saint Etienne
Saint-Etienne, 42270
Chu Strasbourg
Strasbourg, 67091
Chu Tours
Tours, 37044
Belgium3 sites
Ulb - Clinique Saint Luc
Brussels, 1200
Gent University Hospital
Ghent, 9000
CHU LIEGE - Sart Tilman
Liège, 4000
About this study
Official title: Development and Validation of an Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy
The endoscopic capsule is a new tool for exploration of the small intestine. The superiority of this technique on the radiological conventional examinations was shown in Crohn's disease. However no standardization of the lesions exists and no score of severity was proposed. The objective of this exploratory and multicentric study is to develop and validate an endoscopic score of severity especially dedicated to the examination by endoscopic capsule of the small intestine. Hundred twenty patients reached of disease of Crohn corresponding to various groups of severity will be included and will have an examination by video-capsule. The recorded examinations will be the standardized collection of all the lesions observed by independent readers, which will make it possible to evaluate the level of reproducibility of the detection of each lesion. Moreover, each reader will provide his total, qualitative and quantitative evaluations, of the severity of the attack of the small intestine. By using the data of only one reader, a score of severity will be built by simple linear function of the reproducible lesions observed. This score will be validated from the data corresponding to other readers of the same examinations, and those corresponding to another sample. Lastly, the aptitude of this score to detect the changes of the severity of the attack of the small intestine and to define the endoscopic cicatrization will be evaluated from data obtained among patients before and after treatment by infliximab or corticoids
Read the detailed description
primary objective:Development and validation of an endoscopic score of severity of the small intestine adapted to its exploration by capsule among patients with crohn's disease secondary objectives:
- Study of the reproducibility of the detection of the lesions
- total evaluation of the severity of the small intestine (on an ordinal scale with 5 classes and on a continuous analogical scale).
- Study and validation of the sensitivity to the change of the score of severity (variation among patients after treatment by Infliximab or corticoids).
- Evaluation of the aptitude of the endoscopic score of severity to define the endoscopic cicatrization.
- Study of the correlation between the endoscopic score of severity and a clinical marker of activity: Crohn' S Disease Activity Index (CDAI) and a marker of inflammation: serum level of C-Reactive protein (CRP).
- Validation of the utility of "Patency Agile™" used before the capsule. All the patients included will have before their endoscopic capsule an examination by patency. After validation, the patients will have an exploration by the video capsule. The readers will fill a grid with standardized lesions. The films will be read by two other independent readers. The patients treated by infliximab or prednisone will have one second capsule afterwards 10 weeks.
- Conditions
- Crohn's Disease
- Being tested
- wireless endoscopy capsule
- Keywords
- crohn's disease, capsule endoscopes
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wireless endoscopy capsuleDevice
Firslty patency ingestion then wireless endoscopy capsule exam done
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Capsule | Patient enrolled for performing an endoscopic capsule Receives: Device: wireless endoscopy capsule |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud BOURREILLE, MD, Principal investigator, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492791
- Sponsor's protocol ID
- GETAID 2006-2
- Acronym
- CAPSCDEIS
- Status last verified
- Aug 2011
- First submitted
- 26 Jun 2007
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT00492791
- Acronym / sponsor ID
- CAPSCDEIS / GETAID 2006-2
- Conditions
- Crohn's Disease
- Keywords
- crohn's disease, capsule endoscopes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jun 2007 (estimated)
- 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 endoscopic capsule is a new tool for exploration of the small intestine. The superiority of this technique on the radiological conventional examinations was shown in Crohn's disease. However no standardization of the lesions exists and no score of severity was proposed. The objective of this exploratory and multicentric study is to develop and validate an endoscopic score of severity especially dedicated to the examination by endoscopic capsule of the small intestine. Hundred twenty patients reached of disease of Crohn corresponding to various groups of severity will be included and will have an examination by video-capsule. The recorded examinations will be the standardized collection of all the lesions observed by independent readers, which will make it possible to evaluate the level of reproducibility of the detection of each lesion. Moreover, each reader will provide his total, qualitative and quantitative evaluations, of the severity of the attack of the small intestine. By using the data of only one reader, a score of severity will be built by simple linear function of the reproducible lesions observed. This score will be validated from the data corresponding to other readers of the same examinations, and those corresponding to another sample. Lastly, the aptitude of this score to detect the changes of the severity of the attack of the small intestine and to define the endoscopic cicatrization will be evaluated from data obtained among patients before and after treatment by infliximab or corticoids
Detailed description
primary objective:Development and validation of an endoscopic score of severity of the small intestine adapted to its exploration by capsule among patients with crohn's disease secondary objectives:
- Study of the reproducibility of the detection of the lesions
- total evaluation of the severity of the small intestine (on an ordinal scale with 5 classes and on a continuous analogical scale).
- Study and validation of the sensitivity to the change of the score of severity (variation among patients after treatment by Infliximab or corticoids).
- Evaluation of the aptitude of the endoscopic score of severity to define the endoscopic cicatrization.
- Study of the correlation between the endoscopic score of severity and a clinical marker of activity: Crohn' S Disease Activity Index (CDAI) and a marker of inflammation: serum level of C-Reactive protein (CRP).
- Validation of the utility of "Patency Agile™" used before the capsule. All the patients included will have before their endoscopic capsule an examination by patency. After validation, the patients will have an exploration by the video capsule. The readers will fill a grid with standardized lesions. The films will be read by two other independent readers. The patients treated by infliximab or prednisone will have one second capsule afterwards 10 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Capsule | – | Device: wireless endoscopy capsulePatient enrolled for performing an endoscopic capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Active or quiescent Crohn's Disease
Key inclusion criteria (10 listed)
- Patients older than 18 years.
- Crohn's disease diagnosed on clinical, endoscopic, histological criteria. In active or inactive phase of their disease (HBI > 4; CDAI > 150).
- The patients will belong to the one of the 4 groups defined above according to the examinations carried out during the follow-up of the disease.
- Group 1: at least one ileal ulceration at ileocolonoscopy and no radiological abnormality
- Group 2: nonsevere attack on radiological examinations with or without endoscopic lesion
Key exclusion criteria (10 listed)
- ano-perineal location.
- Occlusion or sub-occlusion chronicle or intermittent or if there are frank signs of dilation of small intestine on the morphological examinations.
- Martial treatment since less than ten days before the realization of the capsule.
- Non steroidal anti-inflammatory treatment since less than three months before the realization of the capsule.
- Ileostomy on hail.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wireless endoscopy capsuleFirslty patency ingestion then wireless endoscopy capsule exam done | Device | Endoscopic Capsule |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Arnaud BOURREILLE, MD principal investigator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 20 sites in 2 countries.
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 10 inclusion and 10 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: finished, as of the sponsor's last update on 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 17 Apr 2012.