ASSESSMENT OF THE PERFORMANCE OF THE SECOND GENERATION PILLCAM COLON CAPSULE (PCCE 2) IN CROHN*S DISEASE, BEFORE AND AFTER TREATMENT WITH ANTI-TNF AGENTS OR VEDOLIZUMAB : SENSITIVITY TO CHANGE STUDY

ASSESSMENT OF THE PERFORMANCE OF THE SECOND GENERATION PILLCAM COLON CAPSULE (PCCE 2) IN CROHN*S DISEASE, BEFORE AND AFTER TREATMENT WITH ANTI-TNF AGENTS OR VEDOLIZUMAB : SENSITIVITY TO CHANGE STUDY - STOC study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50462

Enrollment

Registered

2016-04-26

Start date

2016-06-14

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease Inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Active ileocolonic Crohn's disease with CDAI > 150 Elevated faecal calprotectin >250 ug/g and /or increased CRP levels(>5mg/l) and/ or endoscopy showing ulcerations

Exclusion criteria

Exclusion criteria: Any contraindication for colon capsule examination including swallowing disorders, severe congestive heart failure, renal insufficiency or co-morbities contraindicating these procedures. More than 1 bowel resection for CD Previous subtotal or total colectomy Active (draining) fistulas Known small bowel strictures Short bowel syndrome or stoma High suspicion of small bowel strictures. Pacemaker or ICD

Design outcomes

Primary

Measure	Time frame
1. Examine sensitivity and specificity of the PCCE2(Pillcam) to detect mucosal healing in Crohn's patients before and after treatment with Infliximab or Adalimumab or Vedolizumab.	—

Secondary

Measure	Time frame
1. Safety and tolerability of the preparation procedure and the Pillcam examination 2. Determine inter-observer variability by serial readings of Pillcam recordings	—

Countries

Netherlands

Outcome results