Pan-enteric Capsule Endoscopy (PCE)
DeviceSecond generation of colon capsule endoscopy (Medtronic)
NCT Number: NCT03161886
This prospective, interventional study aims this to determine the efficacy and safety of a PCE-based treat-to-target strategy in order to achieve Mucosal Healing (MH) and deep remission (DR) of pediatric Crohn's Disease (CD) over 52 weeks.
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Notify Me6 year–18 year
All sexes
Interventional
Not applicable
This first prospective study on mucosal healing (MH) and deep remission (DR) in pediatric Crohn's Disease aims to evaluate:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Second generation of colon capsule endoscopy (Medtronic)
Time frame: 52 weeks
-The ability of PCE to assess mucosal healing rate (percentage of patients with healing of the mucosa) at three time points and to guide a treat-to-target strategy was the primary outcome sought.
and colonic CD
Time frame: 52 weeks
-The ability of PCE to assess deep remission rate (percentage of patients with healing of the mucosa and absence of symptoms) at three time points and to guide a treat-to-target strategy was the primary outcome sought.
and colonic CD
Time frame: 52 weeks
-The efficacy of a "treat-to-target" strategy to increase percentage of patients with mucosal healing (healing of the mucosa) and deep remission (healing of the mucosa and absence of symptoms) rates over 24 and 52 weeks
Time frame: 52 weeks
percentage of patients with positive finding at PCE, biomarkers, Magnetic Resonance Enterography (MRE) and Small Intestine contrast ultrasonography (SICUS).
Azienda Policlinico Umberto I
Other
A Treat-to-target Strategy Using Pan-enterica Capsule Endoscopy (PCE) in Paediatric Crohn's Disease (CD).
Acronym: PCE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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