Colon CancerDEKORNCT02182466
German Colon Capsule Registry
An observational study of Colon Cancer and Colon Polyp, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colon Polyp, Diarrhea
- What is being tested?
- Colon capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to 30 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication for endoscopic investigation of the colon
Who may be able to join
- Indication for colon capsule endoscopy
- Age of 18 years or older
- Consent of the patient
Who cannot join
- Intestinal obstruction
- Dyphagia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Documentation of Colon Capsule Endoscopies in a National Observational Study [Dokumentation Von Kolonkapsel-Endoskopien im Rahmen Einer Bundesweiten Studie]
Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy.
Read the detailed description
Colon capsule endoscopy (CCE, Pill Cam Colon 2, (Given Imaging Ltd, Yoqneam, Israel and Given Imaging EMEA, Hamburg, Germany) provides direct visualization of the colon mucosa, enabling the investigator to diagnose colonic disease. CCE is a complementary means to flexible ileo-colonoscopy andt safety, quality assurance and quality control of CCE is not well understood. There are about 15 000 investigations performed worldwide until now, but systematic data on performance in a community based setting are lacking.
This study aims to investigate safety, quality assurance and quality control of colon capsule endoscopy.
- Being tested
- Colon capsule endoscopy
- Keywords
- Colon capsule endoscopy, Colonoscopy, Screening colonoscopy
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps, Diarrhea, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon capsule endoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Colonic endoscopy indicated | Not described Receives: Device: Colon capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing a diagnosis from colon capsule endoscopy
Participants will be followed for the time of presentation at the outpatient clinic or for the duration of hospital stay, an expected average of 2 weeks after performance of the investigation
Measured: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Secondary outcomes (3)
Technical success of colon capsule endoscopy
Technical success is evaluated during the investigation and immediately after to identifal correct technical function of the capsule endoscope including technical performance of the system, battery life of the capsule, passage of colon capsule, review of the capsule video, and documentation
Measured: At presentation of the patient for performing colon capsule endoscopy until end of colon capsule endoscopy, an average of 24 hours
Complications of colon capsule endoscopy, i.e. number of participants with Adverse Events and characterization of Adverse Events
Participants will be followed for the time of presentation at the outpatient clinic or for the duration of hospital stay. Thereby, participants with adverse events attributable to colon capsule endoscopy are assessed and AE characterized.
Measured: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Cleansing level of colon capsule endoscopy
Cleansing level of the colon is assessed and qualified as adequate or as not adequate.
Measured: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2014
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorg Albert, Johann Wolfgang Goethe University Hospital
- Investigators
- Jörg G Albert, MD, Principal investigator, Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182466
- Sponsor's protocol ID
- 265/13
- Other IDs
- DRKS-ID: DRKS00006283
- Acronym
- DEKOR
- Status last verified
- Dec 2017
- First submitted
- 27 Jun 2014
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documentation of Colon Capsule Endoscopies in a National Observational Study [Dokumentation Von Kolonkapsel-Endoskopien im Rahmen Einer Bundesweiten Studie]
- ClinicalTrials.gov ID
- NCT02182466
- Acronym / sponsor ID
- DEKOR / 265/13
- Keywords
- Colon capsule endoscopy, Colonoscopy, Screening colonoscopy
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 8 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.
Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy.
Detailed description
Colon capsule endoscopy (CCE, Pill Cam Colon 2, (Given Imaging Ltd, Yoqneam, Israel and Given Imaging EMEA, Hamburg, Germany) provides direct visualization of the colon mucosa, enabling the investigator to diagnose colonic disease. CCE is a complementary means to flexible ileo-colonoscopy andt safety, quality assurance and quality control of CCE is not well understood. There are about 15 000 investigations performed worldwide until now, but systematic data on performance in a community based setting are lacking.
This study aims to investigate safety, quality assurance and quality control of colon capsule endoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic endoscopy indicated | – | Device: Colon capsule endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication for endoscopic investigation of the colon
Key inclusion criteria (3 listed)
- Indication for colon capsule endoscopy
- Age of 18 years or older
- Consent of the patient
Key exclusion criteria (3 listed)
- Intestinal obstruction
- Dyphagia
- Pregnancy
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 capsule endoscopy | Device | Colonic endoscopy indicated |
Primary outcome
Establishing a diagnosis from colon capsule endoscopy
Time frame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Participants will be followed for the time of presentation at the outpatient clinic or for the duration of hospital stay, an expected average of 2 weeks after performance of the investigation
3 secondary outcomes
Technical success of colon capsule endoscopy
Time frame: At presentation of the patient for performing colon capsule endoscopy until end of colon capsule endoscopy, an average of 24 hours
Complications of colon capsule endoscopy, i.e. number of participants with Adverse Events and characterization of Adverse Events
Time frame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Cleansing level of colon capsule endoscopy
Time frame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
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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.
Jörg G Albert, MD principal investigator
Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Colon Polyp, run by Johann Wolfgang Goethe University Hospital at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Dec 2017. 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 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?
The study was stopped early. 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?
Establishing a diagnosis from colon capsule endoscopy (time frame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation). 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 Dec 2017.