Evaluation of PillCam IBD Capsule Endoscopy System in Visualization of Lesions in the Colon Indicative of Ulcerative Colitis Disease

Ulcerative Colitis Clinical Trial

— UC  

Official title:

Evaluation of PillCam IBD Capsule Endoscopy System in Visualization of Lesions in the Colon Indicative of Ulcerative Colitis Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025777
• Other study ID #: RD-210
• Status: Completed
• Phase: N/A
• First received: December 31, 2013
• Last updated: March 2, 2016
• Start date: May 2014
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommitteeSpain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Study Hypothesis UC Disease affects the colon. PillCam IBD may be used for visualization of the colon mucosa in UC Disease patients. This study is designed to evaluate the yield and clinical impact of IBD capsule in detecting lesions associated with UC Disease and to determine the agreement between PillCam Platform with the IBD capsule and optical colonoscopy in the evaluation of UC disease extent.

Primary Scientific Objective To evaluate the agreement between PillCam IBD system and optical colonoscopy in the evaluation of UC disease extent (Non-active disease, Proctitis, Left-sided colitis, Pancolitis)

Proposed Design Established UC disease patients whose clinical condition suggests ongoing disease activity, aged 18 years and up, who have no evidence of symptomatic stricture or other obstruction that would prevent capsule passage will be enrolled in this study.

Patients will undergo bowel prep, followed by a PillCam IBD capsule examination and colonoscopy examination.

The Rapid videos will be evaluated by two readers, each from a different site, the colonoscopy videos will be evaluated by two other physicians, at the sites

INCLUSION CRITERIA

All subjects must fulfill all of the following inclusion criteria:

• Patients ages 18 years and up

• Patient has known UC according to physician discretion

• Patient has at least one positive inflammatory marker from the following:

• ESR

• CRP

• CBC

• Patient is indicated and eligible for a standard of care colonoscopy examination

• Patient agrees to sign consent form

EXCLUSION CRITERIA

The presence of any of the following will exclude a patient from study enrollment:

• Crohn's Disease

• Antibiotic Associated Colitis

• Stool positive for O&P (C&S within 3 months of enrollment)

• Other known infectious cause of increased symptoms

• Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting.

• Definite long stricture seen on radiological exam.

• Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment

• Suspected GI stricture, followed by patency capsule study or other imaging study that could not prove patency of the GI tract.

• Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.

• Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule.

• Patient with known gastrointestinal motility disorders.

• Subjects with known or suspected delayed gastric emptying

• Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

• Patient has Type 1 or Type II Diabetes.

• Patient has any allergy or other known contraindication to the medications used in the study.

• Patient has any condition, which precludes compliance with study and/or device instructions.

• Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.

• Concurrent participation in another clinical trial using any investigational drug or device.

• Patient suffers from a life threatening condition

• Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients ages 18 years and up

• Patient has known UC according to physician discretion

• Patient has symptoms of fresh bleeding and/or bloody diarrhea and/or at least one positive inflammatory marker within the past three months from the following:

• ESR

• CRP

• CBC

• Patient is indicated and eligible for a standard of care colonoscopy examination for evaluation of disease activity and not for routine screening for dysplasia or colorectal cancer

• Patient agrees to sign consent form

Exclusion Criteria:

• Crohn's Disease

• Antibiotic Associated Colitis

• Stool positive for O&P and for C. difficile toxin within 3 months of enrollment

• Other known infectious cause of increased symptoms

• Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting.

• Definite tight or long stricture seen on radiological exam.

• Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment

• Suspected GI stricture, followed by patency capsule study or other imaging study that could not prove patency of the GI tract.

• Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.

• Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule.

• Patient with a known gastrointestinal motility disorder.

• Subjects with known or suspected delayed gastric emptying

• Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

• Patient has Type 1 or Type II Diabetes.

• Patient has any allergy or other known contraindication to the medications used in the study.

• Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.

• Concurrent participation in another clinical trial using any investigational drug or device.

• Patient suffers from a life threatening condition

• Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Capsule Endoscopy

Locations

Country	Name	City	State
Israel	Sheari-Zedek Medical Center	Jerusalem
Spain	Puerta de Hierro	Majadahonda, Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Countries where clinical trial is conducted

Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Type, incidence, severity, and duration of adverse events		9 days after capsule procedure	Yes
Primary	Agreement between PillCam IBD system and optical colonoscopy in the evaluation of UC disease extent (Non-active disease, Proctitis, Left-sided colitis, Pancolitis)		3 weeks post capsule procedure	No
Secondary	• Agreement between PillCam IBD system and optical colonoscopy in the evaluation of UC disease activity based on the Mayo Score (non-active, mild, moderate, severe)		3 weeks after capsule procedure	No