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German Colon Capsule Registry (DEKOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182466
Recruitment Status : Terminated
First Posted : July 8, 2014
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Jorg Albert, Johann Wolfgang Goethe University Hospital

Brief 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.

Condition or disease Intervention/treatment
Colon Cancer Colon Polyp Diarrhea Inflammatory Bowel System Ulcerative Colitis Device: 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.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Documentation of Colon Capsule Endoscopies in a National Observational Study [Dokumentation Von Kolonkapsel-Endoskopien im Rahmen Einer Bundesweiten Studie]
Study Start Date : June 2014
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
Colonic endoscopy indicated Device: Colon capsule endoscopy



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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.

  3. 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 ]
    Cleansing level of the colon is assessed and qualified as adequate or as not adequate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with indication for endoscopic investigation of the colon
Criteria

Inclusion Criteria:

  • Indication for colon capsule endoscopy
  • Age of 18 years or older
  • Consent of the patient

Exclusion Criteria:

  • Intestinal obstruction
  • Dyphagia
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02182466


Locations
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Germany
Frankfurt University Hospital
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Jörg G Albert, MD Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany

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Responsible Party: Jorg Albert, [Dokumentation von Kolonkapsel-Endoskopien im Rahmen einer bundesweiten Studie], Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02182466    
Other Study ID Numbers: 265/13
DRKS-ID: DRKS00006283 ( Other Identifier: German Clinical Trials Registry )
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Keywords provided by Jorg Albert, Johann Wolfgang Goethe University Hospital:
Colon capsule endoscopy
Colonoscopy
Screening colonoscopy
Additional relevant MeSH terms:
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Colitis, Ulcerative
Diarrhea
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Colitis
Gastroenteritis
Inflammatory Bowel Diseases
Signs and Symptoms, Digestive
Signs and Symptoms