Evaluation of the PillCam™ Colon Capsule -2 System

This study has been completed.
Sponsor:
Information provided by:
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00884624
First received: April 20, 2009
Last updated: March 10, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon.


Condition
Bowel Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the PillCam™ Colon Capsule -2 System

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Accuracy parameters of PCCE-2 in detecting colonic polyps as compared to conventional colonoscopy [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Assessment of colon cleansing level at different colon segments [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
  • Distribution of capsule excretion time [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Percent of excreted capsules up to 10 hours post capsule ingestion. [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Number, type and severity of adverse events [ Time Frame: WithIn 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Accuracy parameters of PCCE-2 in detecting colonic lesions as compared to conventional colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Capsule transit time within stomach, small bowel and colon [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Number of polyps and sizes at different colon segments detected by capsule [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • Number of polyps and sizes at different colon segments detected by conventional colonoscopy [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
  • RAPID video reading time [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]
  • Conventional colonoscopy duration including: total time, insertion time, and withdrawal time see my comment above (at the objective section) [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Assessment of the RAPID video [ Time Frame: Within 7 Days ] [ Designated as safety issue: No ]
  • Patient questionnaire [ Time Frame: Within 7 days ] [ Designated as safety issue: No ]

Enrollment: 255
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.

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 500,000 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 PillCam™ Colon Endoscope 1(PCCE-1) system. The new development of PillCam Colon Endoscope 2 (PCCE-2) is primarily aimed to increase sensitivity and specificity for polyp detection.

Further details of the PillCam™ Colon Capsule Endoscope (PCCE-2) can be found in the device description section.

This study is designed to evaluate the performance of the new version of colon capsule and its performance in detecting lesions in the colon as compared to conventional colonoscopy.

  Eligibility

Ages Eligible for Study:   18 Years to 57 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.

Criteria

Inclusion Criteria:

  • Subject is between the ages of 18-57 years.
  • Subject is able and agrees to sign the Informed Consent Form
  • Subject was referred to colonoscopy for at least one of the following reasons:

    • Colorectal cancer screening
    • Clinical symptoms such as: rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits, or diarrhea/constipation of recent onset.
    • Positive findings in the colon on a GI radiographic study
    • Personal history of colorectal cancer (CRC) or adenomatous polyps and at least 5 years since last conventional colonoscopy
    • Positive findings in the colon
    • Personal history of polyps that were removed at least 5 years ago (5 years and more)

Exclusion Criteria:

  • Subject has dysphagia
  • Subject has congestive heart failure
  • Subject has renal insufficiency
  • Subject has Nephrotic syndrome
  • Subject has Cirrhosis
  • Subject is known or is suspected to suffer from intestinal obstruction.
  • Subject is taking NSAID medication
  • Subject suffers from hypertension and is taking one or more of the following medications used for control of hypertension: diuretics, ACE inhibitors, Angiotensin II blockers
  • Chronic use of laxatives
  • Subject has a cardiac pacemakers or other implanted electro medical devices.
  • 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.
  • Age < 18 years or under parent guardian
  • Age>57 years
  • Subject suffers from life threatening conditions
  • Subject is currently participating in another clinical study
  • Subject has known slow gastric emptying time
  • Subject is allergic or contraindicated to any of the study medications
  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: NCT00884624

Locations
Israel
Hillel Yaffe Hospital
Hadera, Israel, 38101
Rambam - Medical center
Haifa, Israel, 31096
Bikkur Holim Hospital
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel, 95347
Rabin Medical Center
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Rami Eliakim, Prof. Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Director Clinical Affiars, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00884624     History of Changes
Other Study ID Numbers: MA-200
Study First Received: April 20, 2009
Last Updated: March 10, 2010
Health Authority: Israel: Ministry of Health
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Given Imaging Ltd.:
Bowel Diseases

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

ClinicalTrials.gov processed this record on September 18, 2014