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| ID | Type | Description | Link |
|---|---|---|---|
| DRKS-ID: DRKS00006283 | Other Identifier | German Clinical Trials Registry |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonic endoscopy indicated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon capsule endoscopy | Device |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indication for endoscopic investigation of the colon
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| Name | Affiliation | Role |
|---|---|---|
| Jörg G Albert, MD | Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frankfurt University Hospital | Frankfurt am Main | Hesse | 60590 | Germany |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003111 | Colonic Polyps |
| D003967 | Diarrhea |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| 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 |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D015212 | Inflammatory Bowel Diseases |
| D013514 | Surgical Procedures, Operative |