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PillCam SBC System Functionality in Established and Suspected IBD Patients | Clinical Trials | Clareo Health

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PillCam SBC System Functionality in Established and Suspected IBD Patients

Evaluation of PillCam SBC Capsule Endoscopy System Performance in Established and Suspected IBD Patients to Assess System Functionality by Visualizing and Assessing the Small Bowel and Colon

NCT02742714•Medtronic - MITG

View on ClinicalTrials.gov

Summary

This clinical study is designed to evaluate the PillCam SBC system performance in 50 established or suspected inflammatory bowel disease (IBD) patients by visualizing and assessing their small and large bowel.

Detailed Description

The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa. Fifty established and suspected IBD patients (at least half of them with established crohn disease (CD)) with active or quiescent disease activity, aged 18 years and up, with no symptomatic stricture or known obstruction that would prevent capsule passage will be enrolled in up to 6 medical sites in Israel and Europe. Patients will undergo bowel prep, followed by a PillCam SBC capsule examination. Patency capsule may precede PillCam SBC ingestion according to physician discretion. The PillCam Software videos will be evaluated by local site reader following a Subjective Assessment Form fulfillment.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients ages 18-75 years, inclusive
•Patient has known crohn disease and/ or ulcerative colitis Or
•Patient suspected to have inflammatory bowel disease and suffers from either:
•Diarrhea for more than 6 weeks and/or
•Abdominal pain for more than 6 weeks and/or
•Extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis and
•Suffers from at least one of the symptoms / lab abnormalities listed below:
•* Positive inflammatory marker (ESR, C reactive protein (CRP), thrombocytosis, fecal lactoferrin, fecal calprotectin) within 3 months prior to enrollment
•* Unexplained anemia (less than normal limits) within 3 months prior to enrollment
•* Hypoalbuminemia (\<3.5 g/dl) within 3 months of enrollment
+8 more criteria

Exclusion Criteria

•Antibiotic Associated Colitis
•Stool positive for Ova \&Parasite and for Clostridium difficile toxin within 3 months of enrollment
•Other known infectious cause of symptoms
•Known or suspected intestinal obstruction
•Non-steroidal anti-inflammatory drugs (twice weekly or more) during the 4 weeks preceding enrollment.
•Suspected or known GI stricture, followed by patency capsule study or other imaging study that could not prove patency of the GI tract
•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
+6 more criteria

Locations (5)

Shaare Zedek Medical Center

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

The Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Italy

Hospital de Navarra

Pamplona, Spain

Key Dates

Start Date

July 1, 2016

Primary Completion Date

March 1, 2017

Completion Date

March 1, 2017

Last Updated

September 19, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Inflammatory Small Bowel DiseaseCrohn's Disease

Interventions

PillCam SBC system

DEVICE

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PillCam SBC System Functionality in Established and Suspected IBD Patients

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease