- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00837304
Colon Capsule Endoscopy Versus Standard Colonoscopy in Ulcerative Colitis
Colon Capsule Endoscopy Versus Standard Colonoscopy in Assessing Disease Activity in Patients With Ulcerative Colitis - A Prospective Trial
The dimension of diagnostic procedures and therapy of chronic inflammatory bowel diseases largely depends on the degree of mucosal inflammation. Video colonoscopy is currently the gold standard in the evaluation of the mucosa in patients with Ulcerative Colitis (UC). PillCam Colon Capsule was developed by Given Imaging, Israel, as possible alternative imaging modality to evaluate mucosal changes in patients with UC. The colonic mucosa can be visualized and recorded by video while the colon capsule passes the colon.
Many patients suffering from UC ask their physician for possible alternative diagnostic imaging because they are uncomfortable with conventional colonoscopy.
The primary aim of the present study is to compare the new Pillcam Colon Capsule with standard colonoscopy with respect to assessing mucosal disease activity and localization of inflamed colonic mucosa in patients with known UC.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Muenster, Tyskland, 48149
- University of Muenster, Dept. of Medicine B
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients over 18 years of age with
- known ulcerative colitis
- Indication for Standard Colonoscopy
- Informed Consent given by the patient
Exclusion Criteria:
- Patient has dysphagia
- Patient has congestive heart failure
- Patient has renal insufficiency
- Patient is known or is suspected to suffer from intestinal obstruction
- Patient has a cardiac pacemaker or other implanted electronical medical devices
- Patient is pregnant
- Patient has had prior abdominal surgery of the GI tract
- Patient has any condition, which precludes compliance with study and/or device instructions.
- Age less than 18
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
UC
Patients with known ulcerative colitis
|
PillCam Colon Capsule: The PillCam Colon capsule has two cameras that enable the device to take video images from both ends.
It is 31.11
mm in size and takes pictures at a rate of 4 frames per second.
The delay mode allows recording of images from the esophagus and the stomach for 5 minutes before the capsule switches into sleep mode for 2 hours to save energy.
Standard Colonoscopy: Pts.
undergo colonoscopy with a video colonoscope (CF H180 AI; Olympus, Tokyo, Japan).
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
a) disease activity of ulcerative colitis (modified Rachmilewitz score) b) extent of colonic manifestation of ulcerative colitis c) accuracy parameters (sensitivity, specificity)
Tidsram: 12 months
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12 months
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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
a) patient comfort b) detection of polyps c) differences in recognition of disease activity (physicians, nurses) d) differences in findings in the group of physicians (inter-observer differences)
Tidsram: 12 months
|
12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Tobias Meister, MD, University of Muenster, Dept. of Medicine B
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Med-B_CCE_vs_SC
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-
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Catholic University of the Sacred HeartAvslutad
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Medtronic - MITGAvslutadCRC-screeningFörenta staterna, Israel
-
Military University Hospital, PragueInstitute for Clinical and Experimental Medicine; Masaryk University; University...Okänd