Colorectal Lesions
Conditions
Keywords
polyps, capsule endoscopy, colonoscopy
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.
Interventions
DEVICEPillCam Colon 2
Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE). Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon.
DEVICEColonoscopy
The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
DOUBLE (Caregiver, Investigator)
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 an appropriate candidate for polyp 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, colonoscopy, sigmoidoscopy etc.), 3. Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) \< 5 years. 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. 6. Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer. 7. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease. 8. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding., including positive FOBT test of any variety 9. Subject is suspected or diagnosed with bowel obstruction. 10. Subject has dysphagia or any swallowing disorder. 11. Subject has congestive heart failure. 12. Subject has Diabetes. 13. 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. 14. Subject has a cardiac pacemaker or other implanted electro medical device. 15. Subject has any allergy or other known contraindication to the medications used in the study. 16. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. 17. 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. 18. Subject with strictures, fistulas and/or chronic constipation. 19. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters. 20. Subject with known gastrointestinal motility disorders. 21. Subject has known delayed gastric emptying. 22. Subject has any condition, which precludes compliance with study and/or device instructions. 23. 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. 24. Subject suffers from life threatening conditions. 25. Subject currently participating in another clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reporting Group This was a single center study where 30 patients were enrolled. No formal sample sizing has been performed as this study was a pilot for a larger multicenter trial.
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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Reporting Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 52.57 years |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 11 Participants |
| Thirty patients were enrolled in the study. | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 6 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity
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.
Time frame: Up to 6 weeks
Population: The accuracy parameters were calculated per subject analysis, i.e. the accuracy events were generated by the larger polyp identified in a given subject.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity | 83 percentage of sensitivity |
| PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity | 50 percentage of sensitivity |
Primary
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity
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.
Time frame: Up to 6 weeks
Population: The accuracy parameters were calculated per subject analysis, i.e. the accuracy events were generated by the larger polyp identified in a given subject.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity | 92 percentage of specificity |
| PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity | 100 percentage of specificity |
Secondary
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity
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.
Time frame: Up to 6 weeks
Population: The accuracy parameters were calculated per segment analysis, i.e. the accuracy events were generated by the larger polyp identified in a given location (5 segments).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity | 80 percentage of sensitivity |
| PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity | 33 percentage of sensitivity |
Secondary
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity
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.
Time frame: Up to 6 weeks
Population: The accuracy parameters were calculated per segment analysis, i.e. the accuracy events were generated by the larger polyp identified in a given location (5 segments).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity | 96 percentage of specificity |
| PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp | Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity | 100 percentage of specificity |