German Colon Capsule Registry

Study Overview
=================
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.

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

Conditions
-----------------
Colon Cancer, Colon Polyp, Diarrhea, Inflammatory Bowel System, Ulcerative Colitis

Intervention / Treatment
-----------------
* Device: Colon capsule endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for colon capsule endoscopy Age of 18 years or older Consent of the patient Exclusion Criteria: Intestinal obstruction Dyphagia Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonic endoscopy indicated<br> | Device: Colon capsule endoscopy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon capsule endoscopy, Colonoscopy, Screening colonoscopy