German Colon Capsule Registry

Terminated

• Conditions: Diarrhea; Colon Cancer; Inflammatory Bowel System; Colon Polyp; Ulcerative Colitis
• Interventions: Device: Colon capsule endoscopy

• Registration Number: NCT02182466
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• Intestinal obstruction
• Dyphagia
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Colonic endoscopy indicated	Colon capsule endoscopy	-

Primary Outcome Measures

Name	Time	Method
Establishing a diagnosis from colon capsule endoscopy	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

Name	Time	Method
Complications of colon capsule endoscopy, i.e. number of participants with Adverse Events and characterization of Adverse Events	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.
Cleansing level of colon capsule endoscopy	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.
Technical success of colon capsule endoscopy	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

Trial Locations

Locations (1)

Frankfurt University Hospital; 🇩🇪 Frankfurt, Hessen, Germany