Inflammatory Bowel DiseasesPECNCT04904224
Diagnosis of Inflammatory Bowel Disease by Examining the Entire Bowel by Pan-intestinal Capsule Endoscopy
A study testing Panintestinal video capsule endoscopy and Colonoscopy in people with Inflammatory Bowel Diseases and Morbus Crohn, run by Robert Bosch Medical Center at 6 sites in Germany.
Trial summary
The aim of this study is to discover inflammatory changes in the gastrointestinal tract in adult patients with suspicion of a chronic inflammatory bowel disease (IBD) by examining the entire bowel, including the small intestine, by using a video capsule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Morbus Crohn
- What is being tested?
- Panintestinal video capsule endoscopy and Colonoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 6 sitesGermany
- Study dates
- 7 Mar 2021to 31 Mar 2023
- 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
- 18 years or older
- Apply one of the following
- Chronic abdominal pain for at least 4 weeks, min. 3/10 points on a visual pain scale
- Persistent diarrhea, Stool frequency of at least 4 per day
- doctor visit due to the mentioned complaints
- Exclusion of an infectious genesis or coeliac disease by serological testing or duodenal biopsy, if necessary
- Consent to study participation
- Fecal calprotectin > 50 µg/g
Who cannot join
- Pregnancy
- metastasized malignoma
- terminal renal insufficiency, renal insufficiency requiring dialysis
- swallowing disorder
- age < 18 years
- lack of consent
Show all 10Show fewer
- infectious genesis of symptomps
- coeliac disease
- Relative contraindication:
- evidence of strictures, strictures or fistulas in the gastrointestinal tract in imaging or in high suggestive symptoms, e.g. Ileus
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Praxis Gersemann
Ditzingen, Baden-Wurttemberg, 71254
Michael Gersemann
- Recruiting
Praxis Escher
Leonberg, Baden-Wurttemberg, 71229
Markus Escher
- Recruiting
Gastroenterologische Schwerpunktpraxis
Stuttgart, Baden-Wurttemberg, 70190
Boris Uhel
Hartmut Goelkel
- Recruiting
Robert Bosch Medical Center
Stuttgart, Baden-Wurttemberg, 70376
Joerg G Albert, 004971181013406, joerg.albert@rbk.de
Bea Poppel, 004971181015453, bea.poppel@web.de
- Recruiting
Gastroenterologie am Pragsattel
Stuttgart, Baden-Wurttemberg, 70469
Oliver Mueller
Marcus Pichler
- Recruiting
Ambulante Gastroenterologie
Stuttgart, Baden-Wurttemberg, 70565
Karl M. Teubner
Dietmar Vogler
About this study
Official title: Use of Pan-intestinal Capsule Endoscopy for Detection of Inflammatory Bowel Disease in the Case of Increased Fecal Calprotectin
The aim of this study is to discover inflammatory changes in the gastrointestinal tract in adult patients with suspicion of a chronic inflammatory bowel disease (IBD) by examining the entire bowel, including the small intestine, by using a video capsule. The study compares the video capsule endoscopy with colonoscopy with the question of inflammation and patient satisfaction with the respective examinations.
The study is aimed at participants who present to a gastroenterologist because of their complaints like persistent abdominal pain or diarrhea. An infectious genesis and celiac disease must be ruled out in advance.
Read more
In addition, the determination of the fecal calprotectin (fCal) is necessary for this study. Fecal calprotectin is a stool marker for the severity of an inflammation of the gastrointestinal tract, an increased fecal calprotectin can be an initial indication for the presence of a chronic inflammatory bowel disease.
As mentioned above, participants will be examined in one of two ways: either with an examination of the small and large intestines using video capsule endoscopy in one examination (i.e. ,panintestinal capsule endoscopy', PICE) or a colonoscopy is performed as the standard treatment. Which of the two methods is used will be decided by lot, electronically controlled.
Colon cleansing is necessary in preparation for both examinations. The advantage of being assigned to the video capsule group is, in addition to showing the entire intestine in one examination, that no sedation is necessary for this examination.
In addition to the examination, participants have to fill out a questionnaire with information about their state of affairs, their well-being and their experience with the examination. After a period of six month the participants will be contact by phone to inquire about their current state of health.
Read the detailed description
People who contact a gastroenterologist because of persistent complaints like abdominal pain or diarrhea are suspicious having an inflammatory bowel disease and maybe meet the eligibility requirements for the study.
After checking the inclusion and exclusion criteria further necessary data (medical history, secondary diagnoses, previous examinations, etc.) as well as laboratory parameters (especially signs of inflammation and fecal calprotectin) are collected. After being informed about the study and potential risks, all patients giving written informed consent and who meet the eligibility requirements will be randomized in an open-label manner (participant and investigator) in a 1:1 ratio to video capsule endscopy intervention or colonoscopy. A follow-up by phone to evaluate the state of health is planned after six months.
The study center and established specialist practices are responsible for the study inclusion.
There will be no recruitment by advertising. Only participants who are introducing themselves due to complaints are offered study participation.
- Conditions
- Inflammatory Bowel Diseases, Morbus Crohn
- Being tested
- Panintestinal video capsule endoscopy, Colonoscopy
- Keywords
- Abdominal Pain, Diarrhea, Video Capsule Endoscopy, Panintestinal Video Capsule Endoscopy, Fecal Calprotectin
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Abdominal Pain, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panintestinal video capsule endoscopyDevice
Also called PillCam Crohn's Capsule
Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic
ColonoscopyDevice
Also called (Ileo-)Colonoscopy
Performing a standard colonoscopy using the colonoscope available in the study center
| Study group | Role | What they receive |
|---|---|---|
| PICE | Active comparator | Participants receive a panintestinal video capsule endoscopy (PICE) Receives: Device: Panintestinal video capsule endoscopy |
| Colonoscopy | Active comparator | Participants receive an (Ileo-)Colonoscopy Receives: Device: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract
Detection of inflammatory changes using vidoe capsule endoscopy or colonoscopy
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Number of Diagnosis of a Chronic Inflammatory Bowel Disease
Diagnosis of inflammatory bowel disease depending on the examination findings of video capsule endoscopy or colonoscopy
Measured: through study completion, an average of 1 year
Number of Participants with Indication for a Therapy because of the Examination findings
Indication for a surgical or drug therapy
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start7 Mar 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized multicentric open-label study in cooperation with local gastroenterological specialist practices. A comparison is made of pan-intestinal capsule endoscopy versus colonoscopy.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jorg G. Albert, Robert Bosch Medical Center
- Investigators
- Joerg G. Albert, Study director, Robert Bosch Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904224
- Sponsor's protocol ID
- KKF-06-2019
- Acronym
- PEC
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Albert JG, Martiny F, Krummenerl A, Stock K, Lesske J, Gobel CM, Lotterer E, Nietsch HH, Behrmann C, Fleig WE. Diagnosis of small bowel Crohn's disease: a prospective comparison of capsule endoscopy with magnetic resonance imaging and fluoroscopic enteroclysis. Gut. 2005 Dec;54(12):1721-7. doi: 10.1136/gut.2005.069427. Epub 2005 Jul 14.
PubMed 16020490Albert JG, Kotsch J, Kostler W, Behl S, Kaltz B, Bokemeyer B, Dollinger MM, Haerting J, Fleig WE. Course of Crohn's disease prior to establishment of the diagnosis. Z Gastroenterol. 2008 Feb;46(2):187-92. doi: 10.1055/s-2007-963524.
PubMed 18253897Carroccio A, Iacono G, Cottone M, Di Prima L, Cartabellotta F, Cavataio F, Scalici C, Montalto G, Di Fede G, Rini G, Notarbartolo A, Averna MR. Diagnostic accuracy of fecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable bowel syndrome: a prospective study in adults and children. Clin Chem. 2003 Jun;49(6 Pt 1):861-7. doi: 10.1373/49.6.861.
PubMed 12765980Cotter J, Dias de Castro F, Moreira MJ, Rosa B. Tailoring Crohn's disease treatment: the impact of small bowel capsule endoscopy. J Crohns Colitis. 2014 Dec;8(12):1610-5. doi: 10.1016/j.crohns.2014.02.018. Epub 2014 Mar 14.
PubMed 24631311Dionisio 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 20029412Fleiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics. 1980 Jun;36(2):343-6.
PubMed 26625475Hale M, McAlindon ME. Capsule endoscopy as a panenteric diagnostic tool. Br J Surg. 2014 Feb;101(3):148-9. doi: 10.1002/bjs.9321. Epub 2013 Nov 19. No abstract available.
PubMed 24254382Hale MF, Drew K, McAlindon ME, Sidhu R. The diagnostic accuracy of faecal calprotectin and small bowel capsule endoscopy and their correlation in suspected isolated small bowel Crohn's disease. Eur J Gastroenterol Hepatol. 2016 Oct;28(10):1145-50. doi: 10.1097/MEG.0000000000000696.
PubMed 27384306Hale MF, Sidhu R, McAlindon ME. Capsule endoscopy: current practice and future directions. World J Gastroenterol. 2014 Jun 28;20(24):7752-9. doi: 10.3748/wjg.v20.i24.7752.
PubMed 24976712Jensen MD, Nathan T, Rafaelsen SR, Kjeldsen J. Diagnostic accuracy of capsule endoscopy for small bowel Crohn's disease is superior to that of MR enterography or CT enterography. Clin Gastroenterol Hepatol. 2011 Feb;9(2):124-9. doi: 10.1016/j.cgh.2010.10.019. Epub 2010 Nov 5.
PubMed 21056692Jensen MD, Kjeldsen J, Nathan T. Fecal calprotectin is equally sensitive in Crohn's disease affecting the small bowel and colon. Scand J Gastroenterol. 2011 Jun;46(6):694-700. doi: 10.3109/00365521.2011.560680. Epub 2011 Apr 1.
PubMed 21456899May A, Albert J, Keuchel M, Moog G, Hartmann D. [Capsule endoscopy for the diagnosis of small bowel diseases. An updated statement by the endoscopy section of DGVS]. Z Gastroenterol. 2010 Dec;48(12):1384-404. doi: 10.1055/s-0029-1245788. Epub 2010 Nov 24. No abstract available. German.
PubMed 21108180Pennazio M, Spada C, Eliakim R, Keuchel M, May A, Mulder CJ, Rondonotti E, Adler SN, Albert J, Baltes P, Barbaro F, Cellier C, Charton JP, Delvaux M, Despott EJ, Domagk D, Klein A, McAlindon M, Rosa B, Rowse G, Sanders DS, Saurin JC, Sidhu R, Dumonceau JM, Hassan C, Gralnek IM. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2015 Apr;47(4):352-76. doi: 10.1055/s-0034-1391855. Epub 2015 Mar 31.
PubMed 25826168Petruzziello C, Calabrese E, Onali S, Zuzzi S, Condino G, Ascolani M, Zorzi F, Pallone F, Biancone L. Small bowel capsule endoscopy vs conventional techniques in patients with symptoms highly compatible with Crohn's disease. J Crohns Colitis. 2011 Apr;5(2):139-47. doi: 10.1016/j.crohns.2010.12.004. Epub 2011 Jan 14.
PubMed 21453883Smalley W, Falck-Ytter C, Carrasco-Labra A, Wani S, Lytvyn L, Falck-Ytter Y. AGA Clinical Practice Guidelines on the Laboratory Evaluation of Functional Diarrhea and Diarrhea-Predominant Irritable Bowel Syndrome in Adults (IBS-D). Gastroenterology. 2019 Sep;157(3):851-854. doi: 10.1053/j.gastro.2019.07.004. Epub 2019 Jul 11. No abstract available.
PubMed 31302098
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Pan-intestinal Capsule Endoscopy for Detection of Inflammatory Bowel Disease in the Case of Increased Fecal Calprotectin
- ClinicalTrials.gov ID
- NCT04904224
- Acronym / sponsor ID
- PEC / KKF-06-2019
- Conditions
- Inflammatory Bowel Diseases, Morbus Crohn
- Keywords
- Abdominal Pain, Diarrhea, Video Capsule Endoscopy, Panintestinal Video Capsule Endoscopy, Fecal Calprotectin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Robert Bosch Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 27 May 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.
The aim of this study is to discover inflammatory changes in the gastrointestinal tract in adult patients with suspicion of a chronic inflammatory bowel disease (IBD) by examining the entire bowel, including the small intestine, by using a video capsule. The study compares the video capsule endoscopy with colonoscopy with the question of inflammation and patient satisfaction with the respective examinations.
The study is aimed at participants who present to a gastroenterologist because of their complaints like persistent abdominal pain or diarrhea. An infectious genesis and celiac disease must be ruled out in advance.
In addition, the determination of the fecal calprotectin (fCal) is necessary for this study. Fecal calprotectin is a stool marker for the severity of an inflammation of the gastrointestinal tract, an increased fecal calprotectin can be an initial indication for the presence of a chronic inflammatory bowel disease.
As mentioned above, participants will be examined in one of two ways: either with an examination of the small and large intestines using video capsule endoscopy in one examination (i.e. ,panintestinal capsule endoscopy', PICE) or a colonoscopy is performed as the standard treatment. Which of the two methods is used will be decided by lot, electronically controlled.
Colon cleansing is necessary in preparation for both examinations. The advantage of being assigned to the video capsule group is, in addition to showing the entire intestine in one examination, that no sedation is necessary for this examination.
In addition to the examination, participants have to fill out a questionnaire with information about their state of affairs, their well-being and their experience with the examination. After a period of six month the participants will be contact by phone to inquire about their current state of health.
Detailed description
People who contact a gastroenterologist because of persistent complaints like abdominal pain or diarrhea are suspicious having an inflammatory bowel disease and maybe meet the eligibility requirements for the study.
After checking the inclusion and exclusion criteria further necessary data (medical history, secondary diagnoses, previous examinations, etc.) as well as laboratory parameters (especially signs of inflammation and fecal calprotectin) are collected. After being informed about the study and potential risks, all patients giving written informed consent and who meet the eligibility requirements will be randomized in an open-label manner (participant and investigator) in a 1:1 ratio to video capsule endscopy intervention or colonoscopy. A follow-up by phone to evaluate the state of health is planned after six months.
The study center and established specialist practices are responsible for the study inclusion.
There will be no recruitment by advertising. Only participants who are introducing themselves due to complaints are offered study participation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized multicentric open-label study in cooperation with local gastroenterological specialist practices. A comparison is made of pan-intestinal capsule endoscopy versus colonoscopy.
| Arm | Type | Receives |
|---|---|---|
| PICE | Active comparator | Device: Panintestinal video capsule endoscopyParticipants receive a panintestinal video capsule endoscopy (PICE) |
| Colonoscopy | Active comparator | Device: ColonoscopyParticipants receive an (Ileo-)Colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years or older
- Apply one of the following
- Exclusion of an infectious genesis or coeliac disease by serological testing or duodenal biopsy, if necessary
- Consent to study participation
- Fecal calprotectin > 50 µg/g
Key exclusion criteria (10 listed)
- Pregnancy
- metastasized malignoma
- terminal renal insufficiency, renal insufficiency requiring dialysis
- swallowing disorder
- age < 18 years
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 |
|---|---|---|
| Panintestinal video capsule endoscopyAlso: PillCam Crohn's CapsulePerforming a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic | Device | PICE |
| ColonoscopyAlso: (Ileo-)ColonoscopyPerforming a standard colonoscopy using the colonoscope available in the study center | Device | Colonoscopy |
Primary outcome
Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract
Time frame: through study completion, an average of 1 year
Detection of inflammatory changes using vidoe capsule endoscopy or colonoscopy
2 secondary outcomes
Number of Diagnosis of a Chronic Inflammatory Bowel Disease
Time frame: through study completion, an average of 1 year
Number of Participants with Indication for a Therapy because of the Examination findings
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Background: PubMed 16020490Albert JG, Martiny F, Krummenerl A, Stock K, Lesske J, Gobel CM, Lotterer E, Nietsch HH, Behrmann C, Fleig WE. Diagnosis of small bowel Crohn's disease: a prospective comparison of capsule endoscopy with magnetic resonance imaging and fluoroscopic enteroclysis. Gut. 2005 Dec;54(12):1721-7. doi: 10.1136/gut.2005.069427. Epub 2005 Jul 14.
- Background: PubMed 18253897Albert JG, Kotsch J, Kostler W, Behl S, Kaltz B, Bokemeyer B, Dollinger MM, Haerting J, Fleig WE. Course of Crohn's disease prior to establishment of the diagnosis. Z Gastroenterol. 2008 Feb;46(2):187-92. doi: 10.1055/s-2007-963524.
- Background: PubMed 12765980Carroccio A, Iacono G, Cottone M, Di Prima L, Cartabellotta F, Cavataio F, Scalici C, Montalto G, Di Fede G, Rini G, Notarbartolo A, Averna MR. Diagnostic accuracy of fecal calprotectin assay in distinguishing organic causes of chronic diarrhea from irritable bowel syndrome: a prospective study in adults and children. Clin Chem. 2003 Jun;49(6 Pt 1):861-7. doi: 10.1373/49.6.861.
- Background: PubMed 24631311Cotter J, Dias de Castro F, Moreira MJ, Rosa B. Tailoring Crohn's disease treatment: the impact of small bowel capsule endoscopy. J Crohns Colitis. 2014 Dec;8(12):1610-5. doi: 10.1016/j.crohns.2014.02.018. Epub 2014 Mar 14.
- 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 26625475Fleiss JL, Tytun A, Ury HK. A simple approximation for calculating sample sizes for comparing independent proportions. Biometrics. 1980 Jun;36(2):343-6.
- Background: PubMed 24254382Hale M, McAlindon ME. Capsule endoscopy as a panenteric diagnostic tool. Br J Surg. 2014 Feb;101(3):148-9. doi: 10.1002/bjs.9321. Epub 2013 Nov 19. No abstract available.
- Background: PubMed 27384306Hale MF, Drew K, McAlindon ME, Sidhu R. The diagnostic accuracy of faecal calprotectin and small bowel capsule endoscopy and their correlation in suspected isolated small bowel Crohn's disease. Eur J Gastroenterol Hepatol. 2016 Oct;28(10):1145-50. doi: 10.1097/MEG.0000000000000696.
- Background: PubMed 24976712Hale MF, Sidhu R, McAlindon ME. Capsule endoscopy: current practice and future directions. World J Gastroenterol. 2014 Jun 28;20(24):7752-9. doi: 10.3748/wjg.v20.i24.7752.
- Background: PubMed 21056692Jensen MD, Nathan T, Rafaelsen SR, Kjeldsen J. Diagnostic accuracy of capsule endoscopy for small bowel Crohn's disease is superior to that of MR enterography or CT enterography. Clin Gastroenterol Hepatol. 2011 Feb;9(2):124-9. doi: 10.1016/j.cgh.2010.10.019. Epub 2010 Nov 5.
- Background: PubMed 21456899Jensen MD, Kjeldsen J, Nathan T. Fecal calprotectin is equally sensitive in Crohn's disease affecting the small bowel and colon. Scand J Gastroenterol. 2011 Jun;46(6):694-700. doi: 10.3109/00365521.2011.560680. Epub 2011 Apr 1.
- Background: PubMed 21108180May A, Albert J, Keuchel M, Moog G, Hartmann D. [Capsule endoscopy for the diagnosis of small bowel diseases. An updated statement by the endoscopy section of DGVS]. Z Gastroenterol. 2010 Dec;48(12):1384-404. doi: 10.1055/s-0029-1245788. Epub 2010 Nov 24. No abstract available. German.
- Individual participant dataSharing planned: No
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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.
Joerg G. Albert study director
Robert Bosch Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panintestinal video capsule endoscopy and Colonoscopy in people with Inflammatory Bowel Diseases and Morbus Crohn, run by Robert Bosch Medical Center at 6 sites in Germany.
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 8 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
Contact Joerg G. Albert (004971181013406, joerg.albert@rbk.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Evidence of inflammatory Alterations in the Gastrointestinal Tract (time frame: through study completion, an average of 1 year). 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 NCT04904224, which also lists 19 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 27 May 2021.