Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
This study has been completed.
Sponsor:
Given Imaging Ltd.
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01372878
First received: June 5, 2011
Last updated: July 4, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study was design to establish the effectiveness of PillCam® Platform with the PillCam® COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to optical colonoscopy.
| Condition | Intervention |
|---|---|
|
Colorectal Lesions |
Device: PillCam® COLON 2 procedure Procedure: Colonoscopy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Screening |
| Official Title: | MA-204: Evaluation of Capsule Endoscopy With 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:
- Number of subjects with polyps compared to colonoscopy [ Time Frame: 1 year, same as study duration ] [ Designated as safety issue: No ]Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm where optical colonoscopy is considered as the standard reference.
Secondary Outcome Measures:
- Number of subjects with polyps compared to colonoscopy [ Time Frame: 1 year, same as study duration ] [ Designated as safety issue: No ]Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 10 mm where optical colonoscopy is considered as the standard reference.
- Number of polyps per location compared to colonoscopy [ Time Frame: 1 year, same as study duration ] [ Designated as safety issue: No ]Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting polyps per location (5 segments) equal to or larger than 6 mm where optical colonoscopy is considered as the standard reference.
- Number of polyps per location compared to colonoscopy [ Time Frame: 1 year, same as study duration ] [ Designated as safety issue: No ]Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting polyps per location (5 segments) equal to or larger than 10 mm where optical colonoscopy is considered as the standard reference.
- Safety [ Time Frame: Study duration - 1 year ] [ Designated as safety issue: Yes ]Type, incidence, severity, and duration of adverse events.
| Enrollment: | 886 |
| Study Start Date: | June 2011 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Device: PillCam® COLON 2 procedure
Subjects will undergo a PillCam® COLON 2 procedure which includes ingestion of the PillCam® COLON 2 capsule. PillCam® COLON 2 is a disposable, ingestible capsule that takes video images throughout the digestive system.
Procedure: Colonoscopy
Subjects will undergo standard Colonoscopy procedure 4-6 weeks after PillCam® COLON 2 procedure.
Standard colonoscopy involves placement of a standard endoscope (a thin, flexible plastic tube) into the anus and into the colon, a tiny camera in the endoscope allows the study doctor to see the surface of the colon.
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subject is between 50 - 75 years of age, and is classified as average risk per the AGA Guidelines on CRC Screening.
- Subject received an explanation about the nature of the study and agrees to provide written informed consent.
Exclusion Criteria:
- Subject has a history of colorectal cancer
- Subjects with history of any positive colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.)
- Subject with history of negative colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) < 5 years as these subjects would be defined not requiring screening in this time frame
- Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
- Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high risk genetic syndrome.
- Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
- Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding, including positive FOBT test of any variety.
- Subject is suspected or diagnosed with bowel obstruction.
- Subject has dysphagia or any swallowing disorder.
- Subject has congestive heart failure.
- Subject has Type 1 or Type II Diabetes.
- 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 has a cardiac pacemaker or other implanted electro medical device.
- Subject has any allergy or other known contraindication to the medications used in the study.
- 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 intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
- Subject with strictures, fistulas and/or chronic constipation.
- Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
- Subject with known 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 or nursing 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.
- Concurrent participation in another clinical trial using any investigational drug or device.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372878
Locations
| United States, Alabama | |
| Alabama Digestive Disorders Center P.C. | |
| Huntsville, Alabama, United States, 35802 | |
| United States, Indiana | |
| Indiana University Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Kentucky | |
| Louisville Gastroenterology Associates | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Missouri | |
| Specialists in Gastroenterology | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Research Associates of New York | |
| New York, New York, United States, 10075 | |
| United States, North Carolina | |
| UNC Chapel Hill Gastroenterology and Hepatology | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Ohio | |
| Dayton Gstroenterology Inc. | |
| Dayton, Ohio, United States, 45440 | |
| United States, Tennessee | |
| Franklin Gastroenterology, PLLC | |
| Franklin, Tennessee, United States, 37067 | |
| United States, Texas | |
| Gastroenterology Consultants, P.A. | |
| Houston, Texas, United States, 77034 | |
| Pasadena Gastroenterology Associates, P.A. | |
| Pasadena, Texas, United States, 77505 | |
| United States, Virginia | |
| Gastroenterology Associates of Tidewater | |
| Chesapeake, Virginia, United States, 23320 | |
| Israel | |
| Soroka University Medical Center | |
| Beer-Sheva, Israel, 84101 | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Bikur Holim Hospital | |
| Jerusalem, Israel | |
| Rabin Medical Center | |
| Petach-Tikwa, Israel, 49100 | |
| The Chaim Sheba Medical Center at Tel-Hashomer | |
| Tel Hashomer, Israel | |
| The Tel-Aviv Sourasky Medical Center | |
| Tel-Aviv, Israel, 64239 | |
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
| Principal Investigator: | Douglas Rex, Prof. | Indiana University Hospital, Indianapolis, IN, USA |
More Information
Additional Information:
No publications provided
| Responsible Party: | Given Imaging Ltd. |
| ClinicalTrials.gov Identifier: | NCT01372878 History of Changes |
| Other Study ID Numbers: | MA-204 |
| Study First Received: | June 5, 2011 |
| Last Updated: | July 4, 2012 |
| Health Authority: | United States: Institutional Review Board Israel: Ministry of Health |
Keywords provided by Given Imaging Ltd.:
|
Polyps Capsule endoscopy Colonoscopy |
ClinicalTrials.gov processed this record on May 23, 2013