PillCam® Platform With the PillCam Crohn's Disease Capsule

NCT01631435 | Completed Phase 1 Results

• 1 other identifier: MA-206
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).

Conditions

Crohn's Disease

Keywords

All subjects will have evidence of active symptoms associated with Crohn's disease

Outcome Measures

Primary Outcomes (1)

• Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon

  the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy. The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy. Each patient was classified as follows: * Active Crohn's disease is likely * Active Crohn's disease is NOT likely "Active Crohn's disease" included the followings lesions: * Aphthous ulceration * Ulcers (other than Aphthous) * Bleeding * Inflammatory stricture Lesions other than the above list were classified as "Non active Crohn's disease."

  All the end points and outcomes measures will be evaluated within 4 months from end of enrollment

Study Arms (1)

bowel prep regimen

OTHER

Each study subject will undergo a bowel preparation followed by a PillCam procedure.

Other: Pillcam colon capsule and PillCam™ Prep Procedure; Device: Ileocolonoscopy

Interventions

Pillcam colon capsule and PillCam™ Prep Procedure OTHER

PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.

bowel prep regimen

Ileocolonoscopy DEVICE

Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure • Ileocolonoscopy with intubation of terminal ileum

bowel prep regimen

Eligibility Criteria

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

You may qualify if:

• Subject ages 18-75 years, inclusive
• Subject has known CD and signs and symptoms of active disease including one of the following:
• Chronic diarrhea
• Chronic abdominal pain
• Rectal bleeding
• Subject has at least one of the following within three months of enrollment:
• Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin)
• Anemia (hemoglobin level below normal reference range)
• Hypoalbuminemia (albumin below normal reference range)
• Weight loss
• Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 90 days prior to enrollment.
• Subject agrees to sign consent form

You may not qualify if:

• Indeterminate Colitis
• Ulcerative Colitis
• Antibiotic Associated Colitis
• Stool positive for Ova \&Parasite and for Clostridium difficile toxin within 3 months of enrollment
• Other known infectious cause of increased symptoms
• Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
• 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 Pillcam Patency study or other imaging study that could not prove patency of the GI tract.
• Subject 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.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subjects with known or suspected delayed gastric emptying
• Subjects with known or suspected delayed Small bowel motility
• Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.
• Subject has Type I or Type II Diabetes.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

IU School of Medicine - Gastroenterology

Indianapolis, Indiana, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ravit Peled , Clinical trials manager
• Organization: Given Imaging- Covidien

Ravit.peled@covidien.com

+972 (4) 909-7894

Study Officials

• Debbra Helper, MD

  Indiana University, Indianapolis , USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: June 29, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 1, 2019
• Results First Posted: March 27, 2015

Record last verified: 2015-03

Locations

US (1)