Colorectal CancerDanCapNCT06475560
Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases
A study testing CCE arm and CC arm in people with Colorectal Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CCE arm and CC arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Nov 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Older than 18 years
- Symptomatic patient referred for colonoscopy assessment
- Able to provide oral and written informed consent
Who cannot join
- Require hospital admission for inpatient colonoscopy
- Previous OC with poor bowel preparation within the last 5 years
- Patient is unable to provide oral and written informed consent
- History of stenosis of the digestive tract
- Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma*
- Patient has a pacemaker/defibrillator
Show all 12Show fewer
- Patient is pregnant or breastfeeding
- Known allergies to the bowel preparation regimen
- Have severe kidney disease
- Known chronic constipation
- Imaging examination suggestive for a colorectal tumour
- Anamnestic suspicion of microscopic colitis, where biopsy is needed *including Whipple
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense C, 5000
Michael B Mortensen, MD, PhD, 45 6541 1857, michael.bau.mortensen@rsyd.dk
Anastasios Koulaouzidis, MD DM PhD, 23 41 49 95 ext. +45, Anastasios.Koulaouzidis@rsyd.dk
About this study
The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed.
One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (<25%-30%) is desirable for patient preference and the economy.
Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.
Read the detailed description
As the sensitivity of CC and CCE is constantly increasing and progressively smaller-size pathologies are detected, the association between detected lesions and patients short- and long-term outcomes is becoming more uncertain. In some cases, such as with the resection of diminutive polyps, the number needed to treat to save one person (approx. 8.000) is very close to the number needed to cause one procedure-related death (10.000). Therefore, there is an increasing need to filter CC candidates and define a realistic threshold for treating or ignoring lesions.
The DanCap study fulfils this need by introducing a renewed approach to the diagnostic pathways using CCE. This approach offers out-of-hospital, accurate bowel diagnostics that allow for the decongestion of endoscopic services, as seen in the UK. It has an upscaling potential for national and international redesign of bowel diagnostics. Several clinical trials have demonstrated the strengths and weaknesses of CCE as compared to CC. The Scottish and English Services have shown the feasibility of routine use of CCE and the CCE-based services confirmed already known data with real-world equivalents regarding CCE's safety and high diagnostic quality. However, there are remaining concerns, primarily due to the high (45-60%) re-investigation rate, which makes the patient experience and cost-efficiency of CCE-based services inferior to that of the conventional CC counterpart. Based on these recent findings, setting up a routine diagnostic pathway for further evaluation of CCE in the clinical routine of patients with a low frequency of positive findings, including cost-efficiency assessment, is highly relevant. Here, introducing methods to predict a patient's findings may be extra relevant in the future. Currently, studies suggest that the use of faecal haemoglobin concentration or the microbiome composition may be useful biomarkers for colorectal cancer or precursor lesions. The predictive potential of these biomarkers in a diagnostic pathway has yet to be sufficiently tested, and more evidence is needed before clinical application is possible.
Our study aims to investigate the DanCap pathway as a viable solution for CCE-based diagnostics in symptomatic patients, considered to have a high need for endoscopic evaluation due to the symptoms compatible with neoplastic disease, as referred from general practice (GP). This approach is expected to be cost-effective and maintain high clinical quality while relieving the burden on endoscopy wards in a Danish setting.
The study will provide data for pathway cost analysis of the CCE-based pathway compared to the traditional colonoscopy pathway based on a realistic medicine outcomes assessment.
The secondary aims are to:
- Compare the polyp detection rate (PDR) and CRC detection rates in both groups
- Investigate the role of FIT-testing and microbiome analyses in CCE-based diagnostics for predictive purposes
- Conditions
- Colorectal Cancer
- Being tested
- CCE arm, CC arm
- Keywords
- colorectal cancer, capsule endoscopy, colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCE armDiagnostic test
Twice a week, patients will attend the in-hospital clinic in groups of four persons. They will bring their completed FIT sample, questionnaire, and the signed consent form. A project nurse will administer the capsules in the morning, and the patients can leave after. When the capsule investigation is completed, patients must return their belt and receiver to the Department of Surgery, OUH. After a few days, the patient will receive an electronic letter with the results and information regarding upcoming steps. Those with positive findings or an incomplete investigation will be given a new appointment according to the current clinical routine. A second questionnaire will be sent to the patient 2 weeks after the completed procedure.
CC armDiagnostic test
Patients will start bowel cleansing according to the instructions. They will bring their completed questionnaire and the signed consent form to the scheduled colonoscopy. They will continue to follow the routine clinical setup for outpatient colonoscopy and will only receive, by digital post, after 2 weeks from the procedure, an extra second questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| CCE arm | Active comparator | Symptomatic patients referred by their GP for a 2 week diagnostic lower gastrointestinal procedure will be randomized in clusters determined by the GP clinic provider number. At the start of the project, odd provider numbers will be referred to CC, and even provider numbers will be referred to CCE. After the inclusion of the first 200 consecutive CCE patients, the two arms will be swapped, i.e., patients from clinics with even provider numbers are referred for CC, and odd provider numbers are referred for CCE. Receives: Diagnostic Test: CCE arm |
| CC arm | Placebo comparator | Symptomatic patients referred by their GP for a 2 week diagnostic lower gastrointestinal procedure will be randomized in clusters determined by the GP clinic provider number. At the start of the project, odd provider numbers will be referred to CC, and even provider numbers will be referred to CCE. After the inclusion of the first 200 consecutive CCE patients, the two arms will be swapped, i.e., patients from clinics with even provider numbers are referred for CC, and odd provider numbers are referred for CCE. Receives: Diagnostic Test: CC arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost consequence analysis
The cost-consequence analysis will draw on data from a variety of sources, including the National Technology Council and their cost outline, administrative data from the Department of Surgery, daily observations by the research team, timeline inputs from the clinical software 'Bookplan', patient and societal resource use from questionnaires, and other relevant information extracted from patients' electronic health records.
The average cost per patient for each study arm will be estimated by integrating cost data from The Treatment Council and Department of Surgery with recorded resource use, into a consolidated estimate.
Measured: 1 year
Secondary outcomes (4)
Reinvestigation rate of CCE
Due to unacceptable technical quality, incomplete examination or positive CCE findings.
Measured: 1 year
Comparative analysis of detection rates for CCE and CC
Polyp detection rate in both pathways, categorized as "<6 mm", "6-9 mm" and ">9 mm"
Measured: 1 year
Predictive value of FIT
Correlation between the detected concentration of haemoglobin in the FIT sample (μg Hb/g of faeces) and positive findings
Measured: 1 year
Gut microbiome
Corelation between the composition of the microbiome (certain types of bacterias from the stool sample-FIT) and positive findings at CCE or CC
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start27 Nov 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-armed prospective clustered case-crossover randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Syddanmark
- Responsible party
- Sponsor
- Investigators
- Anastasios Koulaouzidis, Professor, Principal investigator, OUH og Svendborg Sygehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475560
- Sponsor's protocol ID
- 322-2023-AK
- Acronym
- DanCap
- Status last verified
- Mar 2026
- First submitted
- 20 Jun 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mollers T, Schwab M, Gildein L, Hoffmeister M, Albert J, Brenner H, Jager S. Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials. Endosc Int Open. 2021 Apr;9(4):E562-E571. doi: 10.1055/a-1353-4849. Epub 2021 Apr 12.
PubMed 33860073Deane C, Walker C, Ryan B, O'Connor A, O'Donnell S, Breslin N, McNamara D. High diagnostic yield despite a lower completion rates for inpatient versus outpatient colon and pan-intestinal capsule endoscopy: a nested case-control study. BMC Gastroenterol. 2023 Mar 9;23(1):61. doi: 10.1186/s12876-022-02561-x.
PubMed 36894909Bretthauer M, Loberg M, Wieszczy P, Kalager M, Emilsson L, Garborg K, Rupinski M, Dekker E, Spaander M, Bugajski M, Holme O, Zauber AG, Pilonis ND, Mroz A, Kuipers EJ, Shi J, Hernan MA, Adami HO, Regula J, Hoff G, Kaminski MF; NordICC Study Group. Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death. N Engl J Med. 2022 Oct 27;387(17):1547-1556. doi: 10.1056/NEJMoa2208375. Epub 2022 Oct 9.
PubMed 36214590Huffstetler AN, Fraiman J, Brownlee S, Stoto MA, Lin KW. An Estimate of Severe Harms Due to Screening Colonoscopy: A Systematic Review. J Am Board Fam Med. 2023 May 8;36(3):493-500. doi: 10.3122/jabfm.2022.220320R2. Epub 2023 May 11.
PubMed 37169588MacLeod C, Hudson J, Brogan M, Cotton S, Treweek S, MacLennan G, Watson AJM. ScotCap - A large observational cohort study. Colorectal Dis. 2022 Apr;24(4):411-421. doi: 10.1111/codi.16029. Epub 2022 Jan 3.
PubMed 34935278Jalayeri Nia G, Arasaradnam RP, Koulaouzidis A. Clinical utility of colon capsule endoscopy: a moving target? Ther Adv Gastroenterol. 2023 Oct 9;16:17562848231195680. doi: 10.1177/17562848231195680. eCollection 2023.
PubMed 37822570Deding U, Cortegoso Valdivia P, Koulaouzidis A, Baatrup G, Toth E, Spada C, Fernandez-Urien I, Pennazio M, Bjorsum-Meyer T. Patient-Reported Outcomes and Preferences for Colon Capsule Endoscopy and Colonoscopy: A Systematic Review with Meta-Analysis. Diagnostics (Basel). 2021 Sep 20;11(9):1730. doi: 10.3390/diagnostics11091730.
PubMed 34574071Agache A, Kaalby Moller L, Eskemose SR, Selnes O, Deding U, Bjorsum-Meyer T, Al-Najami I, Hogh A, Schelde-Olesen B, Lofberg C, Kjolhede T, Rasmussen MK, Baatrup G, Koulaouzidis A. Colon Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases (DanCap): Protocol for a Cluster-Allocated Crossover Trial. Diagnostics (Basel). 2026 Aug 20;16(16):2657. doi: 10.3390/diagnostics16162657.
PubMed 42651058
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases
- ClinicalTrials.gov ID
- NCT06475560
- Acronym / sponsor ID
- DanCap / 322-2023-AK
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, capsule endoscopy, colonoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Region Syddanmark
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Jun 2024 (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 Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed.
One solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (<25%-30%) is desirable for patient preference and the economy.
Therefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.
Detailed description
As the sensitivity of CC and CCE is constantly increasing and progressively smaller-size pathologies are detected, the association between detected lesions and patients short- and long-term outcomes is becoming more uncertain. In some cases, such as with the resection of diminutive polyps, the number needed to treat to save one person (approx. 8.000) is very close to the number needed to cause one procedure-related death (10.000). Therefore, there is an increasing need to filter CC candidates and define a realistic threshold for treating or ignoring lesions.
The DanCap study fulfils this need by introducing a renewed approach to the diagnostic pathways using CCE. This approach offers out-of-hospital, accurate bowel diagnostics that allow for the decongestion of endoscopic services, as seen in the UK. It has an upscaling potential for national and international redesign of bowel diagnostics. Several clinical trials have demonstrated the strengths and weaknesses of CCE as compared to CC. The Scottish and English Services have shown the feasibility of routine use of CCE and the CCE-based services confirmed already known data with real-world equivalents regarding CCE's safety and high diagnostic quality. However, there are remaining concerns, primarily due to the high (45-60%) re-investigation rate, which makes the patient experience and cost-efficiency of CCE-based services inferior to that of the conventional CC counterpart. Based on these recent findings, setting up a routine diagnostic pathway for further evaluation of CCE in the clinical routine of patients with a low frequency of positive findings, including cost-efficiency assessment, is highly relevant. Here, introducing methods to predict a patient's findings may be extra relevant in the future. Currently, studies suggest that the use of faecal haemoglobin concentration or the microbiome composition may be useful biomarkers for colorectal cancer or precursor lesions. The predictive potential of these biomarkers in a diagnostic pathway has yet to be sufficiently tested, and more evidence is needed before clinical application is possible.
Our study aims to investigate the DanCap pathway as a viable solution for CCE-based diagnostics in symptomatic patients, considered to have a high need for endoscopic evaluation due to the symptoms compatible with neoplastic disease, as referred from general practice (GP). This approach is expected to be cost-effective and maintain high clinical quality while relieving the burden on endoscopy wards in a Danish setting.
The study will provide data for pathway cost analysis of the CCE-based pathway compared to the traditional colonoscopy pathway based on a realistic medicine outcomes assessment.
The secondary aims are to:
- Compare the polyp detection rate (PDR) and CRC detection rates in both groups
- Investigate the role of FIT-testing and microbiome analyses in CCE-based diagnostics for predictive purposes
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-armed prospective clustered case-crossover randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| CCE arm | Active comparator | Diagnostic Test: CCE armSymptomatic patients referred by their GP for a 2 week diagnostic lower gastrointestinal procedure will be randomized in clusters determined by the GP clinic provider number. At the start of the project, odd provider numbers will be referred to CC, and even provider numbers will be referred to CCE. After the inclusion of the first 200 consecutive CCE patients, the two arms will be swapped, i.e., patients from clinics with even provider numbers are referred for CC, and odd provider numbers are referred for CCE. |
| CC arm | Placebo comparator | Diagnostic Test: CC armSymptomatic patients referred by their GP for a 2 week diagnostic lower gastrointestinal procedure will be randomized in clusters determined by the GP clinic provider number. At the start of the project, odd provider numbers will be referred to CC, and even provider numbers will be referred to CCE. After the inclusion of the first 200 consecutive CCE patients, the two arms will be swapped, i.e., patients from clinics with even provider numbers are referred for CC, and odd provider numbers are referred for CCE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years
- Symptomatic patient referred for colonoscopy assessment
- Able to provide oral and written informed consent
Key exclusion criteria (12 listed)
- Require hospital admission for inpatient colonoscopy
- Previous OC with poor bowel preparation within the last 5 years
- Patient is unable to provide oral and written informed consent
- History of stenosis of the digestive tract
- Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma*
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 |
|---|---|---|
| CCE armTwice a week, patients will attend the in-hospital clinic in groups of four persons. They will bring their completed FIT sample, questionnaire, and the signed consent form. A project nurse will administer the capsules in the morning, and the patients can leave after. When the capsule investigation is completed, patients must return their belt and receiver to the Department of Surgery, OUH. After a few days, the patient will receive an electronic letter with the results and information regarding upcoming steps. Those with positive findings or an incomplete investigation will be given a new appointment according to the current clinical routine. A second questionnaire will be sent to the patient 2 weeks after the completed procedure. | Diagnostic test | CCE arm |
| CC armPatients will start bowel cleansing according to the instructions. They will bring their completed questionnaire and the signed consent form to the scheduled colonoscopy. They will continue to follow the routine clinical setup for outpatient colonoscopy and will only receive, by digital post, after 2 weeks from the procedure, an extra second questionnaire. | Diagnostic test | CC arm |
Primary outcome
Cost consequence analysis
Time frame: 1 year
The cost-consequence analysis will draw on data from a variety of sources, including the National Technology Council and their cost outline, administrative data from the Department of Surgery, daily observations by the research team, timeline inputs from the clinical software 'Bookplan', patient and societal resource use from questionnaires, and other relevant information extracted from patients' electronic health records. The average cost per patient for each study arm will be estimated by integrating cost data from The Treatment Council and Department of Surgery with recorded resource use, into a consolidated estimate.
4 secondary outcomes
Reinvestigation rate of CCE
Time frame: 1 year
Comparative analysis of detection rates for CCE and CC
Time frame: 1 year
Predictive value of FIT
Time frame: 1 year
Gut microbiome
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 33860073Mollers T, Schwab M, Gildein L, Hoffmeister M, Albert J, Brenner H, Jager S. Second-generation colon capsule endoscopy for detection of colorectal polyps: Systematic review and meta-analysis of clinical trials. Endosc Int Open. 2021 Apr;9(4):E562-E571. doi: 10.1055/a-1353-4849. Epub 2021 Apr 12.
- Background: PubMed 36894909Deane C, Walker C, Ryan B, O'Connor A, O'Donnell S, Breslin N, McNamara D. High diagnostic yield despite a lower completion rates for inpatient versus outpatient colon and pan-intestinal capsule endoscopy: a nested case-control study. BMC Gastroenterol. 2023 Mar 9;23(1):61. doi: 10.1186/s12876-022-02561-x.
- Background: PubMed 36214590Bretthauer M, Loberg M, Wieszczy P, Kalager M, Emilsson L, Garborg K, Rupinski M, Dekker E, Spaander M, Bugajski M, Holme O, Zauber AG, Pilonis ND, Mroz A, Kuipers EJ, Shi J, Hernan MA, Adami HO, Regula J, Hoff G, Kaminski MF; NordICC Study Group. Effect of Colonoscopy Screening on Risks of Colorectal Cancer and Related Death. N Engl J Med. 2022 Oct 27;387(17):1547-1556. doi: 10.1056/NEJMoa2208375. Epub 2022 Oct 9.
- Background: PubMed 37169588Huffstetler AN, Fraiman J, Brownlee S, Stoto MA, Lin KW. An Estimate of Severe Harms Due to Screening Colonoscopy: A Systematic Review. J Am Board Fam Med. 2023 May 8;36(3):493-500. doi: 10.3122/jabfm.2022.220320R2. Epub 2023 May 11.
- Background: PubMed 34935278MacLeod C, Hudson J, Brogan M, Cotton S, Treweek S, MacLennan G, Watson AJM. ScotCap - A large observational cohort study. Colorectal Dis. 2022 Apr;24(4):411-421. doi: 10.1111/codi.16029. Epub 2022 Jan 3.
- Background: PubMed 37822570Jalayeri Nia G, Arasaradnam RP, Koulaouzidis A. Clinical utility of colon capsule endoscopy: a moving target? Ther Adv Gastroenterol. 2023 Oct 9;16:17562848231195680. doi: 10.1177/17562848231195680. eCollection 2023.
- Background: PubMed 34574071Deding U, Cortegoso Valdivia P, Koulaouzidis A, Baatrup G, Toth E, Spada C, Fernandez-Urien I, Pennazio M, Bjorsum-Meyer T. Patient-Reported Outcomes and Preferences for Colon Capsule Endoscopy and Colonoscopy: A Systematic Review with Meta-Analysis. Diagnostics (Basel). 2021 Sep 20;11(9):1730. doi: 10.3390/diagnostics11091730.
- Derived from this study: PubMed 42651058Agache A, Kaalby Moller L, Eskemose SR, Selnes O, Deding U, Bjorsum-Meyer T, Al-Najami I, Hogh A, Schelde-Olesen B, Lofberg C, Kjolhede T, Rasmussen MK, Baatrup G, Koulaouzidis A. Colon Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases (DanCap): Protocol for a Cluster-Allocated Crossover Trial. Diagnostics (Basel). 2026 Aug 20;16(16):2657. doi: 10.3390/diagnostics16162657.
- 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.
Anastasios Koulaouzidis, Professor principal investigator
OUH og Svendborg Sygehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCE arm and CC arm in people with Colorectal Cancer, run by Odense University Hospital at 1 site in Denmark.
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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anastasios Koulaouzidis, Professor (23 41 49 95 ext. +45, Anastasios.Koulaouzidis@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost consequence analysis (time frame: 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 NCT06475560, which also lists 8 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 19 Mar 2026.