Crohn's DiseaseCHANCENCT02193802
Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease
A study testing PillCam® COLON 2 and PillCam Crohn's capsules in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 11 sites in 2 countries.
Trial summary
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies. Mucosal healing is a good predictor of long term remission. 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?
- PillCam® COLON 2 and PillCam Crohn's capsules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 11 sitesin 2 countries
- Study dates
- May 2014to Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged more than 18 years
- Subject with at least ileal lesions of Crohn's disease
- Subject with moderate to severe Crohn's disease at baseline, as defined by CDAI > 150,
- Subject accepting to undergo two capsules endoscopy and Ileocolonoscopy procedures
- Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography or MRI enterography, performed within the 6 months prior to enrollment
Who cannot join
- Known gastrointestinal obstruction or strictures based on the clinical picture or pre procedure testing and profile
- Cardiac pacemakers or other implanted electromedical devices
- Swallowing disorders.
- Subject with known slow gastric emptying
- Contraindications to ileocolonoscopy or general anasthesia
- Subject with any condition, which precludes compliance with study and/or device instructions
Show all 10Show fewer
- Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- Subject suffers from life threatening conditions
- Subject currently participating in another clinical study
- Subject has taken NSAID medications less than one month before enrollment
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
France10 sites
CHU Amiens
Amiens, 80054
CHU CAEN
Caen, 14033
CHU Clermont Ferrand
Clermont-Ferrand, 63003
Hôpital Beaujon
Clichy, 92 110
CHU Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
Hôpital Huriez
Lille, 59000
Hôpital Brabois
Nancy, 54000
Hôpital Hôtel Dieu
Nantes, 44093
Hôpital Archet 2
Nice, 06200
Hôpital St Louis
Paris, 75010
About this study
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies.
Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not complete since it does not allow exploration of the small bowel beyond the terminal ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.
Read the detailed description
Crohn's disease is a chronic, inflammatory disorder affecting any part of the gastrointestinal tract but the terminal ileum is the most frequent location involved alone or in combination with other locations. While about one half of patients have involvement of the ileum and large bowel, another third have disease limited to the small bowel.
The disease affects populations around the globe and occurs at any age but tends to have a peak incidence between the ages of 15 and 35. Typical presenting symptoms include abdominal pain and diarrhea. The clinical presentation of Crohn's disease fluctuates throughout the course of the disease. Symptoms and signs usually correlate with mucosal inflammation. The pattern of Crohn's disease viewed on endoscopy has been characterized and is associated with a number of mucosal characteristics such as erythema, swelling, nodularity, strictures, aphthoid ulceration and ulcers of variable size and depth.
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies. Diagnostic yields of 70% have been reported in suspected SB Crohn's disease. In patients with a known Crohn's disease, the superiority of the capsule to detect mucosal lesions of the SB in comparison to any other radiologic technique has also been clearly demonstrated.
A number of studies indicate that mucosal healing is a good predictor of long term remission. In particular, intense therapeutic regimens including purine analogues and biologic therapies like infliximab have been associated with endoscopic mucosal healing. The recently published SONIC trial evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy and the two drugs combined in moderate to severe Crohn's disease patients. Patients who were treated with infliximab monotherapy and with the combination therapy had significantly longer corticosteroid-free clinical remission than those receiving azathioprine alone. Furthermore, mucosal healing, defined as the absence of mucosal ulcerations at week 26, was greater for the combination therapy than each of the monotherapies alone. Based on the results of these studies, obtaining a mucosal healing becomes in clinical practice a new therapeutic objective especially in patients treated by immunosuppressors or anti-TNF-alpha antibodies. In most of the studies, a complete mucosal healing was assessed by the complete disappearance of ulceration. An endoscopic response could be evaluated by the variation of several endoscopic scores of severity, that are either dedicated to the terminal ileon (TI) more the colon i.e. the Crohn's disease endoscopic severity index (CDEIS) or to the SB i.e. the Lewis score. Concerning the evaluation of the mucosal lesions of the SB by the capsule, a new index of severity is being developed in a study conducted by the different centers of the GETAID i.e. the CE-CDEIS. This score will be available in the first semester of 2013 and would be usable for the present study.
Unfortunately, the assessment of mucosal healing by conventional ileocolonoscopy is not complete since it does not allow exploration of the small bowel beyond TI. Thus, while mucosal changes and symptomatic improvement in subjects with SB Crohn's disease (with or without colonic involvement) can be inferred from studies like ACCENT I, direct evidence of the healing of the majority of the small bowel is lacking. In addition, correlation between evidence of mucosal healing and symptoms, as measured by the Crohn's Disease Activity Index (CDAI), has not been found reliable. This may reflect the limitation of viewing the full extent of small bowel ulcerations on the limited examination which is possible with ileocolonoscopy. This may potentially be overcome with the use of capsule endoscopy of the small bowel.
Until now, no study has evaluated the potential treatment-induced changes of the mucosal lesions located in the SB with a capsule and no comparison between the capsule and the ileocolonoscopy has been conducted in the evaluation of the TI which is the segment analyzable by both techniques. For the patients, demonstrate that the capsule is usable to evaluate the mucosal healing, would be a considerable benefit knowing that the capsule do not necessitate an arduous bowel cleansing and a sedation or a general anesthesia.
The proposed study is designed as a pilot study to evaluate the role of capsule endoscopy in Crohn's disease patients, in monitoring the changes in the terminal ileum and small bowel mucosa during Crohn's disease treatment for induction of remission in active Crohn's disease with ileal involvement. Success in this trial may lead to a larger trial to validate the findings.
- Conditions
- Crohn's Disease
- Being tested
- PillCam® COLON 2 and PillCam Crohn's capsules
- Keywords
- Crohn's disease, small bowel (SB), capsule endoscopy, ileocolonoscopy, anti-TNF-alpha antibodies
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam® COLON 2 and PillCam Crohn's capsulesDevice
Patient preparation for PillCam® COLON 2 and PillCam Crohn's capsule procedure:
Patients will drink only clear liquids beginning 12 noon the day prior to the procedure,12 hour fast prior to the procedure and 1 L of PEG on the morning two hours before the capsule ingestion.
Patients can drink clear liquids 2 hours and eat 4 hours post ingestion. Eight hours post ingestion the data recorder should be removed. Patients will confirm excretion of the capsule or as required by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy | Other | CHANCE is a single arm study: all patients will undergo one capsule endoscopy ( PillCam® COLON 2 capsule and PillCam Crohn's) of the whole intestine AND one ileocolonoscopy.
The patients will be then treated according to the preference of their physician and a second capsule endoscopy AND an ileoconoscopy will be performed 6 at 12 months later.
Both exams will be evaluated locally by two independent investigators and all the recorded films will be evaluated and compared by four central readers. Receives: Device: PillCam® COLON 2 and PillCam Crohn's capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment.
PGA will be evaluated based on capsule or Ileocolonoscopy procedures at week 0 and after 6 at 12 months in two ways as follows:
Quantitative PGA assessment: the severity of the disease will be graded on an analogue visual scaled from 0 (no lesions identified) to 10 (lesions of maximum severity identified).
Qualitative PGA assessment: the severity of the disease at weeks 0 and 40 will be classified into one of the following categories:
- No active disease
- Mild disease
- Moderate disease
- Severe disease
Physician global assessment of the disease severity variation will be classified into:
- Definite Improvement
- Slightly improvement
- No change
- Slightly worsening
- Definite Worsening
Disease severity variation will be also quantified by the change in quantitative PGA.
The disease global severity will be later estimated by the two independent local investigators based on the previously capsule small bowel PGA and on the colonoscopy previously colon PGA.
Measured: week 0 and after 6 at 12 months
Secondary outcomes (2)
Lewis score
The local readers will categorize lesions identified in RAPID. The Lewis score will be calculated later using a dedicated feature in the Rapid software, where the outcome is a continuous scale variable.
Measured: week 0 and after 6 at 12 months
Segmental ileal and global CDEIS score
Segmental ileal and global CDEIS score will be evaluated later in continuance way based on ileo-colonoscopy and capsule findings at weeks 0 and after 6 at 12 months.
Measured: week 0 and after 6 at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startMay 2014
- Primary completion30 Dec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Arnaud Bourreille, MD, Principal investigator, CHU Nantes, Service Hépato-gastro-entérologie 1, place Alexis Ricordeau 44093 Nantes Cedex 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193802
- Sponsor's protocol ID
- GETAID 2012-3
- Other IDs
- 2013-A00034-41
- Acronym
- CHANCE
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2014
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Sands B.E. Crohn's Disease. Sleisenger and Fortran's Gastrointestinal and Liver Disease. 8th edition; Volume 2; Saunders Elsevier Publisher; Canada. 2006. pps 2459-2498.
Lichtenstein G.R. The Clinician's Guide to Inflammatory Bowel Disease. Slack Publishers, New Jersey 2003. pps 1-7;16-19; 41-57.
Kornbluth A, Colombel JF, Leighton JA, Loftus E; ICCE. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005 Oct;37(10):1051-4. doi: 10.1055/s-2005-870315. No abstract available.
PubMed 16189789Engstrom P.F. Goosenberg E.B. Diagnosis and Management of Bowel Disease. 1st edition. Professional Communications, Inc. Publisher. Oklahoma. 1999. pps. 169-185.
Sipponen T, Savilahti E, Kolho KL, Nuutinen H, Turunen U, Farkkila M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis. 2008 Jan;14(1):40-6. doi: 10.1002/ibd.20312.
PubMed 18022866Sostegni R, Daperno M, Scaglione N, Lavagna A, Rocca R, Pera A. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003 Jun;17 Suppl 2:11-7. doi: 10.1046/j.1365-2036.17.s2.17.x.
PubMed 12786607Lewis BS, Eisen GM, Friedman S. A pooled analysis to evaluate results of capsule endoscopy trials. Endoscopy. 2005 Oct;37(10):960-5. doi: 10.1055/s-2005-870353.
PubMed 16189768Mow WS, Lo SK, Targan SR, Dubinsky MC, Treyzon L, Abreu-Martin MT, Papadakis KA, Vasiliauskas EA. Initial experience with wireless capsule enteroscopy in the diagnosis and management of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2004 Jan;2(1):31-40. doi: 10.1016/s1542-3565(03)00289-1.
PubMed 15017630Dray X, Vahedi K, Valleur P, Marteau P. Is there any need for video capsule endoscopy evaluation in postduodenal small-bowel polyps detection in familial adenomatous polyposis? Gastrointest Endosc. 2007 Sep;66(3):634; author reply 634-5. doi: 10.1016/j.gie.2007.04.008. No abstract available.
PubMed 17725961Dionisio PM, Gurudu SR, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis. Am J Gastroenterol. 2010 Jun;105(6):1240-8; quiz 1249. doi: 10.1038/ajg.2009.713. Epub 2009 Dec 22.
PubMed 20029412van Assche G, Vermeire S, Rutgeerts P. Mucosal healing and anti TNFs in IBD. Curr Drug Targets. 2010 Feb;11(2):227-33. doi: 10.2174/138945010790309902.
PubMed 20210770D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34. doi: 10.1016/s0016-5085(99)70005-3.
PubMed 10220494Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.
PubMed 12047962Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.
PubMed 20393175Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464. doi: 10.1016/j.gie.2005.08.011.
PubMed 16500392
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT02193802
- Acronym / sponsor ID
- CHANCE / GETAID 2012-3
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, small bowel (SB), capsule endoscopy, ileocolonoscopy, anti-TNF-alpha antibodies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 18 Jul 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 utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies.
Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not complete since it does not allow exploration of the small bowel beyond the terminal ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.
Detailed description
Crohn's disease is a chronic, inflammatory disorder affecting any part of the gastrointestinal tract but the terminal ileum is the most frequent location involved alone or in combination with other locations. While about one half of patients have involvement of the ileum and large bowel, another third have disease limited to the small bowel.
The disease affects populations around the globe and occurs at any age but tends to have a peak incidence between the ages of 15 and 35. Typical presenting symptoms include abdominal pain and diarrhea. The clinical presentation of Crohn's disease fluctuates throughout the course of the disease. Symptoms and signs usually correlate with mucosal inflammation. The pattern of Crohn's disease viewed on endoscopy has been characterized and is associated with a number of mucosal characteristics such as erythema, swelling, nodularity, strictures, aphthoid ulceration and ulcers of variable size and depth.
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies. Diagnostic yields of 70% have been reported in suspected SB Crohn's disease. In patients with a known Crohn's disease, the superiority of the capsule to detect mucosal lesions of the SB in comparison to any other radiologic technique has also been clearly demonstrated.
A number of studies indicate that mucosal healing is a good predictor of long term remission. In particular, intense therapeutic regimens including purine analogues and biologic therapies like infliximab have been associated with endoscopic mucosal healing. The recently published SONIC trial evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy and the two drugs combined in moderate to severe Crohn's disease patients. Patients who were treated with infliximab monotherapy and with the combination therapy had significantly longer corticosteroid-free clinical remission than those receiving azathioprine alone. Furthermore, mucosal healing, defined as the absence of mucosal ulcerations at week 26, was greater for the combination therapy than each of the monotherapies alone. Based on the results of these studies, obtaining a mucosal healing becomes in clinical practice a new therapeutic objective especially in patients treated by immunosuppressors or anti-TNF-alpha antibodies. In most of the studies, a complete mucosal healing was assessed by the complete disappearance of ulceration. An endoscopic response could be evaluated by the variation of several endoscopic scores of severity, that are either dedicated to the terminal ileon (TI) more the colon i.e. the Crohn's disease endoscopic severity index (CDEIS) or to the SB i.e. the Lewis score. Concerning the evaluation of the mucosal lesions of the SB by the capsule, a new index of severity is being developed in a study conducted by the different centers of the GETAID i.e. the CE-CDEIS. This score will be available in the first semester of 2013 and would be usable for the present study.
Unfortunately, the assessment of mucosal healing by conventional ileocolonoscopy is not complete since it does not allow exploration of the small bowel beyond TI. Thus, while mucosal changes and symptomatic improvement in subjects with SB Crohn's disease (with or without colonic involvement) can be inferred from studies like ACCENT I, direct evidence of the healing of the majority of the small bowel is lacking. In addition, correlation between evidence of mucosal healing and symptoms, as measured by the Crohn's Disease Activity Index (CDAI), has not been found reliable. This may reflect the limitation of viewing the full extent of small bowel ulcerations on the limited examination which is possible with ileocolonoscopy. This may potentially be overcome with the use of capsule endoscopy of the small bowel.
Until now, no study has evaluated the potential treatment-induced changes of the mucosal lesions located in the SB with a capsule and no comparison between the capsule and the ileocolonoscopy has been conducted in the evaluation of the TI which is the segment analyzable by both techniques. For the patients, demonstrate that the capsule is usable to evaluate the mucosal healing, would be a considerable benefit knowing that the capsule do not necessitate an arduous bowel cleansing and a sedation or a general anesthesia.
The proposed study is designed as a pilot study to evaluate the role of capsule endoscopy in Crohn's disease patients, in monitoring the changes in the terminal ileum and small bowel mucosa during Crohn's disease treatment for induction of remission in active Crohn's disease with ileal involvement. Success in this trial may lead to a larger trial to validate the findings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopy | Other | Device: PillCam® COLON 2 and PillCam Crohn's capsulesCHANCE is a single arm study: all patients will undergo one capsule endoscopy ( PillCam® COLON 2 capsule and PillCam Crohn's) of the whole intestine AND one ileocolonoscopy. The patients will be then treated according to the preference of their physician and a second capsule endoscopy AND an ileoconoscopy will be performed 6 at 12 months later. Both exams will be evaluated locally by two independent investigators and all the recorded films will be evaluated and compared by four central readers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject aged more than 18 years
- Subject with at least ileal lesions of Crohn's disease
- Subject with moderate to severe Crohn's disease at baseline, as defined by CDAI > 150,
- Subject accepting to undergo two capsules endoscopy and Ileocolonoscopy procedures
- Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography or MRI enterography, performed within the 6 months prior to enrollment
Key exclusion criteria (10 listed)
- Known gastrointestinal obstruction or strictures based on the clinical picture or pre procedure testing and profile
- Cardiac pacemakers or other implanted electromedical devices
- Swallowing disorders.
- Subject with known slow gastric emptying
- Contraindications to ileocolonoscopy or general anasthesia
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 |
|---|---|---|
| PillCam® COLON 2 and PillCam Crohn's capsulesPatient preparation for PillCam® COLON 2 and PillCam Crohn's capsule procedure: Patients will drink only clear liquids beginning 12 noon the day prior to the procedure,12 hour fast prior to the procedure and 1 L of PEG on the morning two hours before the capsule ingestion. Patients can drink clear liquids 2 hours and eat 4 hours post ingestion. Eight hours post ingestion the data recorder should be removed. Patients will confirm excretion of the capsule or as required by the investigator. | Device | Endoscopy |
Primary outcome
Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment.
Time frame: week 0 and after 6 at 12 months
PGA will be evaluated based on capsule or Ileocolonoscopy procedures at week 0 and after 6 at 12 months in two ways as follows: Quantitative PGA assessment: the severity of the disease will be graded on an analogue visual scaled from 0 (no lesions identified) to 10 (lesions of maximum severity identified). Qualitative PGA assessment: the severity of the disease at weeks 0 and 40 will be classified into one of the following categories: * No active disease * Mild disease * Moderate disease * Severe disease Physician global assessment of the disease severity variation will be classified into: * Definite Improvement * Slightly improvement * No change * Slightly worsening * Definite Worsening Disease severity variation will be also quantified by the change in quantitative PGA. The disease global severity will be later estimated by the two independent local investigators based on the previously capsule small bowel PGA and on the colonoscopy previously colon PGA.
2 secondary outcomes
Lewis score
Time frame: week 0 and after 6 at 12 months
Segmental ileal and global CDEIS score
Time frame: week 0 and after 6 at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- BackgroundSands B.E. Crohn's Disease. Sleisenger and Fortran's Gastrointestinal and Liver Disease. 8th edition; Volume 2; Saunders Elsevier Publisher; Canada. 2006. pps 2459-2498.
- BackgroundLichtenstein G.R. The Clinician's Guide to Inflammatory Bowel Disease. Slack Publishers, New Jersey 2003. pps 1-7;16-19; 41-57.
- Background: PubMed 16189789Kornbluth A, Colombel JF, Leighton JA, Loftus E; ICCE. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005 Oct;37(10):1051-4. doi: 10.1055/s-2005-870315. No abstract available.
- BackgroundEngstrom P.F. Goosenberg E.B. Diagnosis and Management of Bowel Disease. 1st edition. Professional Communications, Inc. Publisher. Oklahoma. 1999. pps. 169-185.
- Background: PubMed 18022866Sipponen T, Savilahti E, Kolho KL, Nuutinen H, Turunen U, Farkkila M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis. 2008 Jan;14(1):40-6. doi: 10.1002/ibd.20312.
- Background: PubMed 12786607Sostegni R, Daperno M, Scaglione N, Lavagna A, Rocca R, Pera A. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003 Jun;17 Suppl 2:11-7. doi: 10.1046/j.1365-2036.17.s2.17.x.
- Background: PubMed 16189768Lewis BS, Eisen GM, Friedman S. A pooled analysis to evaluate results of capsule endoscopy trials. Endoscopy. 2005 Oct;37(10):960-5. doi: 10.1055/s-2005-870353.
- Background: PubMed 15017630Mow WS, Lo SK, Targan SR, Dubinsky MC, Treyzon L, Abreu-Martin MT, Papadakis KA, Vasiliauskas EA. Initial experience with wireless capsule enteroscopy in the diagnosis and management of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2004 Jan;2(1):31-40. doi: 10.1016/s1542-3565(03)00289-1.
- Background: PubMed 17725961Dray X, Vahedi K, Valleur P, Marteau P. Is there any need for video capsule endoscopy evaluation in postduodenal small-bowel polyps detection in familial adenomatous polyposis? Gastrointest Endosc. 2007 Sep;66(3):634; author reply 634-5. doi: 10.1016/j.gie.2007.04.008. No abstract available.
- Background: PubMed 20029412Dionisio PM, Gurudu SR, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis. Am J Gastroenterol. 2010 Jun;105(6):1240-8; quiz 1249. doi: 10.1038/ajg.2009.713. Epub 2009 Dec 22.
- Background: PubMed 20210770van Assche G, Vermeire S, Rutgeerts P. Mucosal healing and anti TNFs in IBD. Curr Drug Targets. 2010 Feb;11(2):227-33. doi: 10.2174/138945010790309902.
- Background: PubMed 10220494D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34. doi: 10.1016/s0016-5085(99)70005-3.
- sponsor linkLink 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.
Dr Arnaud Bourreille, MD principal investigator
CHU Nantes, Service Hépato-gastro-entérologie 1, place Alexis Ricordeau 44093 Nantes Cedex 1
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam® COLON 2 and PillCam Crohn's capsules in people with Crohn's Disease, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 11 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 5 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: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Spain. 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?
Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment. (time frame: week 0 and after 6 at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02193802, which also lists 17 linked publications.
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 9 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.