Evaluation of PillCam™ Colon 2 in Visualization of the Colon

This study has been completed.
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01063231
First received: October 18, 2009
Last updated: November 25, 2010
Last verified: November 2010
  Purpose

Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.


Condition Intervention Phase
Colonic Diseases
and Large Bowel Diseases
Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of PillCam™ Colon 2 in Visualization of the Colon

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Accuracy parameters of PillCam™ COLON 2 in detecting patients with colonic polyps ≥6mm and ≥10 mm as compared to conventional colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic yield of PillCam™ COLON 2 in detecting colonic lesions as compared to conventional colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Assessment of colon cleansing level at different colon segments for PillCam and Colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Distribution of capsule excretion time up to 10 hours post ingestion based on Rapid videos [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Capsule transit time within stomach, small bowel and colon based on Rapid videos [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Prevalence of polyps at different size categories and locations as detected by capsule and by conventional colonoscopy [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
  • RAPID reading time Number, type and severity of adverse events [ Time Frame: with in 7 days ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule
Medical Device

Detailed Description:

Standard evaluation of subjects with suspected colon diseases includes endoscopic imaging by colonoscopy and radiology testing such as: air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy.

The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.

The PillCam™ SB capsule (formerly M2A® Capsule) that was cleared by the FDA- in August 2001 for small bowel evaluation has been ingested to date by more than 1,000,000 people worldwide and is well accepted by patients and physicians as well as the professional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, the development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. To date, several clinical studies have been conducted with Given® Diagnostic System and the PillCam™ Colon 1 capsule A pilot multicenter study is currently being conducted with a new Given® Diagnostic System and an advanced generation of the the PillCam™ Colon capsule - PillCam™ Colon 2. Capsule. The new development of Given® Diagnostic System and PillCam™ Colon 2 capsule is primarily aimed to increase sensitivity and specificity for polyp detection.

Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section.

This study is designed to evaluate the performance of the new version of Given® Diagnostic System and PillCam™ Colon 2 capsule in detecting patients with polyps and other colonic lesions as compared to conventional colonoscopy.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subject is between the ages of 18-80
  • Subject was referred to colonoscopy for at least one of the following reasons:

    • Colorectal cancer screening for age ≥50
    • Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits for age ≥50
    • Positive findings in the colon (e.g. Polyp ≥10mm)
    • Personal history of polyps that were removed at least 3 years ago (3 years and above)

Exclusion criteria

  • Subject has dysphagia or any swallowing disorder
  • Subject has congestive heart failure
  • Subject has high risk of renal insufficiency associated with the use of sodium phosphate
  • Subject is not eligible for colon preparation due to the presence of underlying conditions based on the clinical judgment of the investigator
  • Subject has any allergy or other known contraindication to the medications used in the study
  • 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 a cardiac pacemaker or other implanted electro medical device.
  • Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  • Subject with any condition believed to have an increased risk for capsule retention such as Crohn's disease, intestinal tumors, radiation enteritis, incomplete colonoscopies due to obstructions or NSAID enteropathy,
  • Subject with gastrointestinal motility disorders
  • Subject has known delayed gastric emptying
  • Subject has any condition, which precludes compliance with study and/or device instructions.
  • Women who are either pregnant at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
  • Subject suffers from life threatening conditions
  • Subject currently participating in another clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063231

Locations
Belgium
Hospital Erasme - Gastro-Enterologie
Brussels, Belgium, 1070
France
Chef de Service dHepato-Gastro-Enterologie et dAssistance Nutritionnelle CHU Nantes
Nantes, France, 44093
CHU Nancy
Vandoeuvre Cedex, France, 54511
Germany
Evangelisches Krankenhaus
Dusseldorf, Germany, 40217
Italy
Ospedale Gemelli,ENDOSCOPIA DIGESTIVA
Roma, Italy, 00168
Netherlands
Academic Medical Center University of Amsterdam
Amsterdam, Netherlands, 1100
Spain
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Sweden
Malmo University Hospital
Malmo, Sweden
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Guido Costamagna, Prof. Ospedale Gemelli
Principal Investigator: Guido Costamagna, Prof Ospedale Gemelli
  More Information

No publications provided

Responsible Party: Director Clinical Affiars, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01063231     History of Changes
Other Study ID Numbers: MA-201
Study First Received: October 18, 2009
Last Updated: November 25, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Given Imaging Ltd.:
Colonic Diseases
bowel diseases

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014