German Colon Capsule Registry

Ulcerative Colitis Clinical Trial

— DEKOR  

Official title:

Documentation of Colon Capsule Endoscopies in a National Observational Study [Dokumentation Von Kolonkapsel-Endoskopien im Rahmen Einer Bundesweiten Studie]

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02182466
• Other study ID #: 265/13
• Secondary ID: DRKS-ID: DRKS000
• Status: Terminated
• Phase: N/A
• First received: June 27, 2014
• Last updated: December 13, 2017
• Start date: June 2014
• Est. completion date: March 30, 2017

Study information

• Verified date: December 2017
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for colon capsule endoscopy

• Age of 18 years or older

• Consent of the patient

Exclusion Criteria:

• Intestinal obstruction

• Dyphagia

• Pregnancy

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Colon Cancer
• Colon Polyp
• Diarrhea
• Inflammatory Bowel System
• Ulcerative Colitis

Intervention

Device:
• Colon capsule endoscopy

Locations

Country	Name	City	State
Germany	Frankfurt University Hospital	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Secondary	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	At presentation of the patient for performing colon capsule endoscopy until end of colon capsule endoscopy, an average of 24 hours
Secondary	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.	At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Secondary	Cleansing level of colon capsule endoscopy	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