Overview

This trial is active, not recruiting.

Conditions colon cancer, colon polyp, diarrhea, inflammatory bowel system, ulcerative colitis
Treatment colon capsule endoscopy
Sponsor Johann Wolfgang Goethe University Hospitals
Start date June 2014
End date December 2016
Trial size 600 participants
Trial identifier NCT02182466, 265/13, DRKS-ID: DRKS00006283

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
colon capsule endoscopy

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Documentation of Colon Capsule Endoscopies in a National Observational Study [Dokumentation Von Kolonkapsel-Endoskopien im Rahmen Einer Bundesweiten Studie]
Principal investigator Jörg G Albert, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Johann Wolfgang Goethe University Hospitals.