CRC Screening
Conditions
Keywords
Polyps, Capsule endoscopy, Colonoscopy
Brief summary
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.
Detailed description
This multi-center study was designed to evaluate the safety and effectiveness of PillCam Platform with the PillCam COLON 2 capsule as demonstrated by the identification of subjects with polyps, compared to optical colonoscopy. 884 subjects participated in this study. All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps. Each subject was required to follow a bowel preparation regimen and to undergo capsule endoscopy (CE) followed by optical colonoscopy (OC). The optical colonoscopy procedure was scheduled 4-6 weeks after CE procedure to allow for the central readers reading of the PillCam RAPID video. The colonoscopist was kept blinded to the CE results
Interventions
DEVICEPillCam® 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.
PROCEDUREColonoscopy
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.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is between 50 - 75 years of age, and is classified as average risk per the AGA Guidelines on CRC Screening. 2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.
Exclusion criteria
1. Subject has a history of colorectal cancer 2. Subjects with history of any positive colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) 3. 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 4. 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. 5. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high risk genetic syndrome. 6. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease. 7. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding, including positive FOBT test of any variety. 8. Subject is suspected or diagnosed with bowel obstruction. 9. Subject has dysphagia or any swallowing disorder. 10. Subject has congestive heart failure. 11. Subject has Type 1 or Type II Diabetes. 12. 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. 13. Subject has a cardiac pacemaker or other implanted electro medical device. 14. Subject has any allergy or other known contraindication to the medications used in the study. 15. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. 16. 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. 17. Subject with strictures, fistulas and/or chronic constipation. 18. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters. 19. Subject with known gastrointestinal motility disorders. 20. Subject has known delayed gastric emptying. 21. Subject has any condition, which precludes compliance with study and/or device instructions. 22. 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. 23. Subject suffers from life threatening conditions. 24. Concurrent participation in another clinical trial using any investigational drug or device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference | 1 year, same as study duration | Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard. Sensitivity measures the proportion of actual positives which are correctly identified as such. Specificity measures the proportion of negatives which are correctly identified as such. positive event defined as patients with polyps ≥6 mm detected by OC procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference | 1 year, same as study duration | Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard. |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Colon Capsule Endoscopy, Then Standard Colonoscopy Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison | 884 |
| Total | 884 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | incomplete study procedure | 104 |
| Overall Study | Protocol Violation | 17 |
| Overall Study | Withdrawal by Subject | 63 |
Baseline characteristics
| Characteristic | Colon Capsule Endoscopy, Then Standard Colonoscopy |
|---|---|
| Age, Continuous | 57.29 years STANDARD_DEVIATION 5.84 |
| Region of Enrollment Israel | 326 participants |
| Region of Enrollment United States | 558 participants |
| Sex: Female, Male Female | 487 Participants |
| Sex: Female, Male Male | 397 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 110 / 884 |
| serious Total, serious adverse events | 1 / 884 |
Outcome results
Primary
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference
Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard. Sensitivity measures the proportion of actual positives which are correctly identified as such. Specificity measures the proportion of negatives which are correctly identified as such. positive event defined as patients with polyps ≥6 mm detected by OC procedure.
Time frame: 1 year, same as study duration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Colon Capsule Endoscopy, Then Standard Colonoscopy | Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference | sensitivity of patients with Polyp>= 6 mm | 69 percentage of participants |
| Colon Capsule Endoscopy, Then Standard Colonoscopy | Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference | specificty of patients with Polyp>= 6 mm | 87 percentage of participants |
Secondary
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference
Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.
Time frame: 1 year, same as study duration
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Colon Capsule Endoscopy, Then Standard Colonoscopy | Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference | sensitivity of patients with Polyp>= 10 mm | 64 percentage of participants |
| Colon Capsule Endoscopy, Then Standard Colonoscopy | Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference | specificity of patients with Polyp>= 10 mm | 95 percentage of participants |