Inflammatory Bowel DiseaseVICCOINBODINCT02129972
Colon Capsule Endoscopy in Children
A study testing Colon videocapsule endoscopy (PillCam colon 2) in people with Inflammatory Bowel Disease, run by Hospices Civils de Lyon at 7 sites in France.
Trial summary
The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in adults as in children. The colonoscopy is considered as the gold standard exam for the diagnosis and the follow-up of the patients presenting or suspected to have an IBD. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Colon videocapsule endoscopy (PillCam colon 2)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 7 sitesFrance
- Study dates
- Apr 2014to Apr 2018
- Phase
- Interventional
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Will be included in this study are patients:
- Presenting a suspected or confirmed Inflammatory Bowel Disease (IBD) such as Crohn Disease, Ulcerative Colitis or undetermined colitis and who are referred for a conventional colonoscopy;
- Between 8 and 18 years old
- Who are not participating in other clinical trials
- For who a written informed consent was obtained
- Having successfully performed a candy test and the bowel permeability test (using the Patency Alagile ® capsule)
Who cannot join
- Will not be included in this study are patients:
- Presenting a contra indication for colonoscopy under general sedation or for the ingestion of the colon video capsule, especially those for who exist a clinical or radiological suspicion of upper gastrointestinal strictures (esophageal surgery or eosinophil esophagitis) and who presents a dysphagia to solids, swallowing disorders with or without impaired consciousness.
- Who underwent an abdominal surgery during the last 3 months prior to the inclusion visit or who presents signs of bowel stenosis or occlusion
- Who presents a toxic mega colon, radic enteritis, intestinal bowel carcinoma or who receives a chronically non-steroidal anti-inflammatory treatment
- Presenting a contra indication for the bowel preparation agents
- With cardiac pacemaker or other implanted electro medical devices susceptible to interfere with the colon video capsule
- Scheduled for a magnetic resonance imaging (MRI) examination within 7 days following the ingestion of the colon video capsule (and until the evacuation of the capsule has been confirmed) or any other life-threatening conditions
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux
Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron
Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille
Lille
Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP
Paris
Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP
Paris
Service de Pédiatrie, Hôpital Sud, CHU de Rennes
Rennes
Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse
Toulouse
About this study
Official title: Evaluation of the Video Capsule Colonoscopy for the Detection and the Control of Colon Lesions in Children Presenting Confirmed or Suspected Inflammatory Bowel Disease
The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in adults as in children. The colonoscopy is considered as the gold standard exam for the diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The follow-up and financial management of this kind of pathology is very much dependent on the quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique which assumes a general sedation, many efforts have been done to develop new less expensive and less invasive techniques in order to offer alternatives to the classic colon endoscopy. One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 - Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique which has been successfully validated with adults. We hypothesize that the CVC can be used in children with similar results in terms of efficacy, as is the case for adults.
This prospective simple blind multicenter study, will investigate the diagnostic value of the CVC compared to the conventional colonoscopy under general sedation for the detection and the control of colon lesions in children presenting IBD.
Read more
If the feasibility and the efficacy of the colon video capsule technique are also proven for use with children, then this new technique might become a very interesting alternative for the endoscopic examination of the colon because of being less expensive and less invasive.
Moreover, this technique would be very useful as a means of lesions detection all along the digestive tract and not limited to the colon only.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Colon videocapsule endoscopy (PillCam colon 2)
- Keywords
- Inflammatory Bowel Disease, colon lesions, colon capsule endoscopy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon videocapsule endoscopy (PillCam colon 2)Device
Also called PillCam colon 2
This is a simple blind (blind for the lecture of the CVC record) study to evaluate the diagnostic value of the colon capsule endoscopy for the detection and the control of colon lesions, the feasibility, tolerance and safety of the CVC compared to the conventional colonoscopy under general sedation in children presented with Inflammatory Bowel Disease.
Over one week, the patient will undergo two exams (CVC and colonoscopy under general sedation). The exams will be done by two different physicians.
In order to assess the tolerance, after the completion of both exams, the patients will be asked to answer a "comfort score" questionnaire.
In order to assess the safety of the CVC, the patients will have a follow-up for adverse events over a 3 weeks period after completion of the CVC and only if the colon video capsule was not recovered during the conventional colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| video capsule endoscopy | Experimental | Not described Receives: Device: Colon videocapsule endoscopy (PillCam colon 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic value of the wireless colon capsule endoscopy
The diagnostic value of the colon video capsule will be estimated based upon the calculated sensitivity of the colon video capsule for the detection and the control of colon lesions in children presented with IBD compared to the colonoscopy sensitivity.
Measured: 1 week after the completion of the colon video capsule exam .
Secondary outcomes (5)
Diagnostic and predictive value of the colon video capsule
The diagnostic value expressed by the specificity, positive and negative predictive values of the colon video capsule compared to the results of the colonoscopy under general sedation.
Measured: 1 week after the completion of the colon video capsule exam
Diagnostic performance of the colon video capsule
Percentage of the colon lesions successfully detected by the colon video capsule compared to the results recorded during the colonoscopy.
Measured: 1 week after the completion of both endoscopic exams
Evaluation of the feasibility and the acceptability by the patient of the colon video capsule compared to the colonoscopy under general sedation
Based upon the comfort score calculated after a comfort questionnaire that the patient has been completed after the colon video capsule exam and colonoscopy have been performed
Measured: 1 week after the completion of the colon video capsule exam
Evaluation of the efficacy of the bowel preparation before the endoscopic examination of the colon
The evaluation will be done using the Boston score.
Measured: 1 week after the colon video capsule has been performed
Descriptive analysis of the visualization and the progression of the colon video capsule over the different segments of the bowel
The analysis will be based upon the description of the different lesions and the time of capsule progression in each bowel segment during the video capsule exam. The different segments will be defined taking into account the anatomic landmarks.
Measured: 1 week after the colon video capsule has been performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ALAIN LACHAUX, MD, Principal investigator, HOPITAL FEMME MERE ENFANT CHU DE LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129972
- Sponsor's protocol ID
- 2013-823
- Acronym
- VICCOINBODI
- Status last verified
- Oct 2018
- First submitted
- 29 Apr 2014
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Video Capsule Colonoscopy for the Detection and the Control of Colon Lesions in Children Presenting Confirmed or Suspected Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02129972
- Acronym / sponsor ID
- VICCOINBODI / 2013-823
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Inflammatory Bowel Disease, colon lesions, colon capsule endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 2 May 2014 (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 incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in adults as in children. The colonoscopy is considered as the gold standard exam for the diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The follow-up and financial management of this kind of pathology is very much dependent on the quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique which assumes a general sedation, many efforts have been done to develop new less expensive and less invasive techniques in order to offer alternatives to the classic colon endoscopy. One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 - Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique which has been successfully validated with adults. We hypothesize that the CVC can be used in children with similar results in terms of efficacy, as is the case for adults.
This prospective simple blind multicenter study, will investigate the diagnostic value of the CVC compared to the conventional colonoscopy under general sedation for the detection and the control of colon lesions in children presenting IBD.
If the feasibility and the efficacy of the colon video capsule technique are also proven for use with children, then this new technique might become a very interesting alternative for the endoscopic examination of the colon because of being less expensive and less invasive.
Moreover, this technique would be very useful as a means of lesions detection all along the digestive tract and not limited to the colon only.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video capsule endoscopy | Experimental | Device: Colon videocapsule endoscopy (PillCam colon 2) |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Presenting a suspected or confirmed Inflammatory Bowel Disease (IBD) such as Crohn Disease, Ulcerative Colitis or undetermined colitis and who are referred for a conventional colonoscopy;
- Between 8 and 18 years old
- Who are not participating in other clinical trials
- For who a written informed consent was obtained
- Having successfully performed a candy test and the bowel permeability test (using the Patency Alagile ® capsule)
Key exclusion criteria (7 listed)
- Presenting a contra indication for colonoscopy under general sedation or for the ingestion of the colon video capsule, especially those for who exist a clinical or radiological suspicion of upper gastrointestinal strictures (esophageal surgery or eosinophil esophagitis) and who presents a dysphagia to solids, swallowing disorders with or without impaired consciousness.
- Who underwent an abdominal surgery during the last 3 months prior to the inclusion visit or who presents signs of bowel stenosis or occlusion
- Who presents a toxic mega colon, radic enteritis, intestinal bowel carcinoma or who receives a chronically non-steroidal anti-inflammatory treatment
- Presenting a contra indication for the bowel preparation agents
- With cardiac pacemaker or other implanted electro medical devices susceptible to interfere with the colon video capsule
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 |
|---|---|---|
| Colon videocapsule endoscopy (PillCam colon 2)Also: PillCam colon 2This is a simple blind (blind for the lecture of the CVC record) study to evaluate the diagnostic value of the colon capsule endoscopy for the detection and the control of colon lesions, the feasibility, tolerance and safety of the CVC compared to the conventional colonoscopy under general sedation in children presented with Inflammatory Bowel Disease. Over one week, the patient will undergo two exams (CVC and colonoscopy under general sedation). The exams will be done by two different physicians. In order to assess the tolerance, after the completion of both exams, the patients will be asked to answer a "comfort score" questionnaire. In order to assess the safety of the CVC, the patients will have a follow-up for adverse events over a 3 weeks period after completion of the CVC and only if the colon video capsule was not recovered during the conventional colonoscopy. | Device | video capsule endoscopy |
Primary outcome
The diagnostic value of the wireless colon capsule endoscopy
Time frame: 1 week after the completion of the colon video capsule exam .
The diagnostic value of the colon video capsule will be estimated based upon the calculated sensitivity of the colon video capsule for the detection and the control of colon lesions in children presented with IBD compared to the colonoscopy sensitivity.
5 secondary outcomes
Diagnostic and predictive value of the colon video capsule
Time frame: 1 week after the completion of the colon video capsule exam
Diagnostic performance of the colon video capsule
Time frame: 1 week after the completion of both endoscopic exams
Evaluation of the feasibility and the acceptability by the patient of the colon video capsule compared to the colonoscopy under general sedation
Time frame: 1 week after the completion of the colon video capsule exam
Evaluation of the efficacy of the bowel preparation before the endoscopic examination of the colon
Time frame: 1 week after the colon video capsule has been performed
Descriptive analysis of the visualization and the progression of the colon video capsule over the different segments of the bowel
Time frame: 1 week after the colon video capsule has been performed
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 15 Jul 2019.
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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.
ALAIN LACHAUX, MD principal investigator
HOPITAL FEMME MERE ENFANT CHU DE LYON
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon videocapsule endoscopy (PillCam colon 2) in people with Inflammatory Bowel Disease, run by Hospices Civils de Lyon at 7 sites 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 6 inclusion and 7 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 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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.
What does the primary outcome measure?
The diagnostic value of the wireless colon capsule endoscopy (time frame: 1 week after the completion of the colon video capsule exam .). 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 15 Jul 2019.