German Colon Capsule Registry (DEKOR)

December 13, 2017 updated by: Jorg Albert, Johann Wolfgang Goethe University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Frankfurt University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with indication for endoscopic investigation of the colon

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Intestinal obstruction
  • Dyphagia
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
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
Cleansing level of the colon is assessed and qualified as adequate or as not adequate.
At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Jörg G Albert, MD, Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 30, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Actual)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 265/13
  • DRKS-ID: DRKS00006283 (Other Identifier: German Clinical Trials Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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