NCT03933371|Unknown
Predictors of Poor Bowel Cleansing and Capsule Endoscopy (CEPREDICT)
CEPREDICT
Risk Factors of Inadequate Bowel Cleansing in Colon Capsule Endoscopy
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CEPREDICT
Risk Factors of Inadequate Bowel Cleansing in Colon Capsule Endoscopy
Sponsor study identifier
observational
403
0 countries
N/A
Study Start
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The main purpose of the study is to determine risk factors of poor bowel cleansing in patients referred for colon capsule endoscopy (CCE) examination. Patients will be prepared with polyethylene glycol (PEG), and a booster by using oral low volume sodium phosphate (NaP) and sodium-amidotrizoate and meglumine-amidotrizoate (Gastrografin ®) The investigators also will try to design a predictive score of poor bowel cleansing and to validate the Bowel cleansing score designed by Leighton and modified by Spada
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 28, 2019
Actual (reported)May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2019
Actual (reported)November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Colon cleansing
Quality of bowel cleansing assessed by the Spada Bowel Preparation Scale. Cleansing is classified from 1 ( no preparation) to 4 (excellent preparation) in each of the 4 segments of the colon (proximal colon, transverse colon, distal colon and rectum)
[Time frame: 20 months][Designated as safety issue: No]
The capsule endoscopy will be ingested by the participant. This device captures images along the large bowel. This images are stored in an external memory and afterwards they are downloaded in a computer
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All patients referred for colon capsule endoscopy meeting inclusion and exclusion criteria will be included in the study. Spanish hospitals with the availability of colon capsule endoscopy will be invited to participate in the study
Spada C, Hassan C, Munoz-Navas M, Neuhaus H, Deviere J, Fockens P, Coron E, Gay G, Toth E, Riccioni ME, Carretero C, Charton JP, Van Gossum A, Wientjes CA, Sacher-Huvelin S, Delvaux M, Nemeth A, Petruzziello L, de Frias CP, Mayershofer R, Amininejad L, Dekker E, Galmiche JP, Frederic M, Johansson GW, Cesaro P, Costamagna G. Second-generation colon capsule endoscopy compared with colonoscopy. Gastrointest Endosc. 2011 Sep;74(3):581-589.e1. doi: 10.1016/j.gie.2011.03.1125. Epub 2011 May 20.
Alarcon-Fernandez O, Ramos L, Adrian-de-Ganzo Z, Gimeno-Garcia AZ, Nicolas-Perez D, Jimenez A, Quintero E. Effects of colon capsule endoscopy on medical decision making in patients with incomplete colonoscopies. Clin Gastroenterol Hepatol. 2013 May;11(5):534-40.e1. doi: 10.1016/j.cgh.2012.10.016. Epub 2012 Oct 16.
Antonio Z Gimeno Garcia, MD, PhD
Hospital Universitario de Canarias
First Submitted
April 28, 2019
First Posted
May 1, 2019
Study Start
May 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2020
Estimated (date passed)Can Pan-Colonic Chromoendoscopy (PCC) Improve Adenoma Detection Rate in FIT-Positive-Patients: A Randomized Study
Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
Contact the study team to confirm eligibility.
Spada C, Hassan C, Galmiche JP, Neuhaus H, Dumonceau JM, Adler S, Epstein O, Gay G, Pennazio M, Rex DK, Benamouzig R, de Franchis R, Delvaux M, Deviere J, Eliakim R, Fraser C, Hagenmuller F, Herrerias JM, Keuchel M, Macrae F, Munoz-Navas M, Ponchon T, Quintero E, Riccioni ME, Rondonotti E, Marmo R, Sung JJ, Tajiri H, Toth E, Triantafyllou K, Van Gossum A, Costamagna G; European Society of Gastrointestinal Endoscopy. Colon capsule endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2012 May;44(5):527-36. doi: 10.1055/s-0031-1291717. Epub 2012 Mar 2.
Spada C, Hassan C, Costamagna G. Colon capsule endoscopy. Gastrointest Endosc Clin N Am. 2015 Apr;25(2):387-401. doi: 10.1016/j.giec.2014.11.007. Epub 2015 Jan 28.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 7, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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