PillCam SBC System Functionality in Established and Suspected IBD Patients

NCT02742714 | Completed

• 1 other identifier: COVGIRD0546
• Study Type: interventional
• Target: 54
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Chronic Inflammatory Small Bowel Disease; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Successful SBC procedure in terms of video creation and report generation per training instructions

  Success procedures are being measured. Only if both video and report will be created it will be defined as success.

  4 weeks

Study Arms (1)

PillCam SBC

EXPERIMENTAL

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.

Device: PillCam SBC system

Interventions

PillCam SBC system DEVICE

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.

Also known as: PillCam Endoscopy system

PillCam SBC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Positive IBD serology within 3 months of enrollment
• Recurrent Fevers
• Unexplained weight loss
• Gastro-intestinal bleeding including melena and/or hematochezia and/or fecal occult blood test (FOBT) positive.
• Chronic perianal disease (fistula, fissure, peri-rectal abscess)

You may not qualify if:

• 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
• Patient has any allergy or other known contraindication or intolerance 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (5)

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

The Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Italy

Location

Hospital de Navarra

Pamplona, Spain

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Abraham Eliakim, Prof.

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: April 19, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); IT (1); IL (3)