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PillCam® Platform With the PillCam Crohn's Disease Capsule

This study is currently recruiting participants.
Verified July 2012 by Given Imaging Ltd.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01631435
First received: June 28, 2012
Last updated: January 17, 2013
Last verified: July 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Crohn's Disease
 Other: Pillcam colon capsule and PillCam™ Prep Procedure
Device: Ileocolonoscopy
 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 the PillCam® Platform With the PillCam Crohn's Disease Capsule in Visualization of Lesions in the Small Bowel and Colon That May Indicate Crohn's Disease

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • 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 [ Time Frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • per-subject diagnostic yield of the PillCam Platform with the CD capsule within the proximal small bowel [ Time Frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment ] [ Designated as safety issue: No ]
    • The number of subjects having active Crohn's disease in their proximal small bowel as detected by the PillCam Platform with the CD capsule.

  • per-segment diagnostic yield of the PillCam Platform with the CD capsule within the terminal ileum and colon as compared to ileocolonoscopy diagnostic yield within the terminal ileum and colon [ Time Frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment ] [ Designated as safety issue: No ]
    • The number of segments per subject having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy.

  • • To evaluate the safety of the PillCam Platform with the CD capsule procedure [ Time Frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment ] [ Designated as safety issue: Yes ]
    • Type, incidence, severity, and duration of adverse events


Estimated Enrollment: 75
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
bowel prep regimen
Each study subject will undergo a bowel preparation followed by a PillCam procedure.
 Other: Pillcam colon capsule and PillCam™ Prep Procedure
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.
Device: Ileocolonoscopy

Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure

• Ileocolonoscopy with intubation of terminal ileum

Detailed Description:

This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below:

Visit 1; Screening visit

  • Informed consent process
  • screening for eligibility to participate in the study
  • Inclusion/exclusion criteria
  • Small bowel patency test
  • Demographic data
  • Pregnancy test
  • General medical history

Visit 2; PillCam® Crohn's capsule ingestion

  • PillCam® CD bowel preparation
  • Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)
  • Ileocolonoscopy with intubation of terminal ileum

Follow up period (5-9 days following visit 2)

• CE Follow up telephone contac

  Eligibility

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

Inclusion Criteria:

  1. Subject ages 18-75 years, inclusive

  2. Subject has known CD and signs and symptoms of active disease including one of the following:

    • Chronic diarrhea
    • Chronic abdominal pain
    • Rectal bleeding

  3. 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
  4. 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.
  5. Subject agrees to sign consent form

Exclusion Criteria:

  1. Indeterminate Colitis
  2. Ulcerative Colitis
  3. Antibiotic Associated Colitis
  4. Stool positive for Ova &Parasite and for Clostridium difficile toxin within 3 months of enrollment
  5. Other known infectious cause of increased symptoms
  6. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
  7. Definite long stricture seen on radiological exam.
  8. Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
  9. Suspected GI stricture, followed by Pillcam Patency study or other imaging study that could not prove patency of the GI tract.
  10. 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.
  11. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  12. Subjects with known or suspected delayed gastric emptying
  13. Subjects with known or suspected delayed Small bowel motility
  14. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.
  15. Subject has Type I or Type II Diabetes.
  16. Subject has any allergy or other known contraindication to the medications used in the study.
  17. Subject has any condition, which precludes compliance with study and/or device instructions.
  18. 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.
  19. Concurrent participation in another clinical trial using any investigational drug or device.
  20. Subject suffers from a life threatening condition.
  21. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631435

Locations
United States, Indiana
IU School of Medicine - Gastroenterology Recruiting
Indianapolis, Indiana, United States
Contact: Gwen Cook     317-948-9212     ; gkcook@iupui.edu    
Principal Investigator: Debbra Helper, MD            
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Debbra Helper, MD Indiana University, Indianapolis , USA
  More Information

No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01631435     History of Changes
Other Study ID Numbers: MA-206
Study First Received: June 28, 2012
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Given Imaging Ltd.:
All subjects will have evidence of active symptoms associated with Crohn's disease

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

ClinicalTrials.gov processed this record on May 16, 2013