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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
Health authority
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

Study Design


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
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