Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon

Not Applicable

Completed

Conditions: Colorectal Lesions

Interventions: Device: PillCam Colon 2
Device: Colonoscopy

Registration Number: NCT01269372

Lead Sponsor: Medtronic - MITG

Brief Summary: This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy.

This study will also use to evaluate the administrative feasibility and data management of study design.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Subject is between 50 - 75 years of age, and an appropriate candidate for polyp 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, colonoscopy, sigmoidoscopy etc.),
Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) < 5 years.
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.
Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer.
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 Diabetes.
Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months or other 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.
Subject currently participating in another clinical study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PillCam Colon 2 and Standard Colonoscopy	PillCam Colon 2	All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy.
PillCam Colon 2 and Standard Colonoscopy	Colonoscopy	All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy.

Primary Outcome Measures

Name	Time	Method
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity	Up to 6 weeks	PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity	Up to 6 weeks	PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

Secondary Outcome Measures

Name	Time	Method
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity	Up to 6 weeks	PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity	Up to 6 weeks	PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.