Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients (RD-207)

This study is currently recruiting participants.
Verified September 2013 by Given Imaging Ltd.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01576120
First received: April 5, 2012
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.


Condition Intervention Phase
Crohn's Disease
Other: Pilcam colon capsule and PillCam™ Prep Procedure
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients- Pivotal Study

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • • Evaluate the effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients [ Time Frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment ] [ Designated as safety issue: No ]

    effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng:

    • Bowel preparation cleansing level assessment at the different GI segments (i.e., per colon segment, terminal ileum and proximal SB).
    • Distribution of PillCam COLON 2 transit times through the colon and the entire GI tract
    • PillCam COLON 2 excretion rate

    The duration of the procedure in this study is 1 day of colon preparation and

    1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted.



Secondary Outcome Measures:
  • • Evaluate the safety of the PillCam COLON2 bowel prep regimen in Crohn's Disease patients [ Time Frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment ] [ Designated as safety issue: Yes ]

    Evaluation of the safety of the PillCam COLON2 bowel prep regimen in Crohn's Disease patients will be measured by analysing the Number, type and severity of adverse events.

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



Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bowel prep regimen
Each study subject will undergo a bowel preparation followed by a PillCam procedure.
Other: Pilcam colon capsule and PillCam™ Prep Procedure
PillCam® COLON 2 bowel 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.

Detailed Description:
  1. Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients.

    Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients

  2. Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time.
  3. The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients

All end points will be evaluated within 4 months from end of enrollment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is 18 years of age and above

    • Subjects who are determined by their physician to have active Crohn's disease based on at least one of the following tests which were performed in the past 3 months :

      • Colonoscopy
      • Capsule endoscopy of the small bowel or colon
      • Other radiology tests
      • Clinical symptoms with elevated positive inflammatory markers ;ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, or fecal alpha-1 antitrypsin
    • Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment
    • Subject is able and agrees to sign the Informed Consent Form

Exclusion Criteria:

  • • Subject has dysphagia

    • Subject has congestive heart failure
    • Subject has renal insufficiency
    • Subject has cirrhosis
    • Subject is known or is suspected to suffer from intestinal obstruction
    • Subject has known previous stricture/obstruction of the SB or colon
    • Chronic use of laxatives
    • Subject has a cardiac pacemaker or other implanted electro medical device.
    • Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
    • Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
    • Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
    • Subject has any condition, which precludes compliance with study and/or device instructions.
    • Subject suffers from life threatening conditions
    • Subject is currently participating in another clinical study
    • Subject has known slow gastric emptying time or GI transit time.
    • Subject is allergic or contraindicated to any of the study medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576120

Locations
United States, Georgia
Atlanta Gastroenterology Associates Recruiting
Atlanta, Georgia, United States, 30342
Contact: Ashleigh Arnold    404-257-9000      
Principal Investigator: Douglas Wolf, MD         
United States, Ohio
Dayton Gastroenterology Recruiting
Beavercreek, Ohio, United States, 45440
Contact: Susan Kesler    037-320-5050      
Contact: Susan Kesler         
Principal Investigator: David Romeo, MD         
Sponsors and Collaborators
Given Imaging Ltd.
  More Information

No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01576120     History of Changes
Other Study ID Numbers: RD-207
Study First Received: April 5, 2012
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Given Imaging Ltd.:
Known, active Crohn's disease
Iieocolonic or colonic involvement
proven patency of the GI tract

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014