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German Colon Capsule Registry

NCT ID: NCT02182466

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-03-30

Brief Summary

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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

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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.

Conditions

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Colon Cancer Colon Polyp Diarrhea Inflammatory Bowel System Ulcerative Colitis

Keywords

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Colon capsule endoscopy Colonoscopy Screening colonoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Colonic endoscopy indicated

Colon capsule endoscopy

Intervention Type DEVICE

Interventions

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Colon capsule endoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Intestinal obstruction
* Dyphagia
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jorg Albert

[Dokumentation von Kolonkapsel-Endoskopien im Rahmen einer bundesweiten Studie]

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jörg G Albert, MD

Role: PRINCIPAL_INVESTIGATOR

Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany

Locations

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Frankfurt University Hospital

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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DRKS-ID: DRKS00006283

Identifier Type: OTHER

Identifier Source: secondary_id

265/13

Identifier Type: -

Identifier Source: org_study_id