Status:
COMPLETED
Evaluation of the PillCam™ Colon Capsule -2 System
Lead Sponsor:
Medtronic - MITG
Conditions:
Bowel Diseases
Eligibility:
All Genders
18-57 years
Brief Summary
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.
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 colon...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00884624
Start Date
March 1 2009
End Date
March 1 2010
Last Update
July 31 2019
Active Locations (5)
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1
Hillel Yaffe Hospital
Hadera, Israel, 38101
2
Rambam - Medical center
Haifa, Israel, 31096
3
Bikkur Holim Hospital
Jerusalem, Israel
4
Meir Medical Center
Kfar Saba, Israel, 95347