Colonic Diseases
Conditions
Keywords
Suspected colonic disease, Known colonic disease
Brief summary
To see if PillCam COLON will demonstrate diagnostic yield \>80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
Detailed description
The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease. This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).
Interventions
DEVICEPillCam COLON
The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.
PROCEDUREStandard colonoscopy
Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.
Sponsors
Medtronic - MITG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject was referred for colonoscopy for one of the following reasons: * Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset. * Any subject ≥ 18 years of age with: * Positive findings in the colon on a GastroIntestinal (GI) radiographic study * Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy * Suspected or known ulcerative colitis
Exclusion criteria
* Subject has dysphagia * Subject has congestive heart failure * Subject has renal insufficiency * Subject is known or is suspected to suffer from intestinal obstruction. * 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 * Subject suffers from life threatening conditions * Subject is currently participating in another clinical study * Subject has known slow gastric emptying time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies | 1 day | The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported. |
| Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | 1 day | Since the standard colonoscopy is the gold standard to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger. |
| Sensitivity of Capsule Endoscopy for Indicated Lesions | 1 day | Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy. |
| Specificity of Capsule Endoscopy for Indicated Lesions | 1 day | Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants With Scoring Index 3 or 4 | 1 day | Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: 1. poor cleansing level (Large amount of fecal residue.) 2. fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.) 3. good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.) 4. excellent cleansing level (No more than small bits of adherent feces.) |
| Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon) | within 7 days | — |
| Number, Type and Severity of Adverse Events | Within 7 days | — |
| Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy | within 7 days | — |
| Percentage of Excreted Colon Capsules | Within 7 days | — |
Countries
France, Germany, Italy, Spain, United Kingdom
Participant flow
Recruitment details
8 Hospital sites
Pre-assignment details
Four patients withdrew before completing the study documents and were not included in the analysis.An additional 8 patients were not included in the analysis of the accuracy of polyp detection.
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. | 328 |
| Total | 328 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Colon Capsule Endoscopy, Then Standard Colonoscopy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 101 Participants |
| Age, Categorical Between 18 and 65 years | 227 Participants |
| Age, Continuous | 58.5 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Belgium | 47 participants |
| Region of Enrollment France | 96 participants |
| Region of Enrollment Germany | 49 participants |
| Region of Enrollment Italy | 53 participants |
| Region of Enrollment Spain | 63 participants |
| Region of Enrollment United Kingdom | 20 participants |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 328 | 0 / 328 |
| serious Total, serious adverse events | 0 / 328 | 0 / 328 |
Outcome results
Primary
Number of Participants With Indicated Lesions Detected by Standard Colonoscopy
Since the standard colonoscopy is the gold standard to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger.
Time frame: 1 day
Population: Participants in the Accuracy Analysis successfully had both capsule endoscopy and colonoscopy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Advanced Adenoma, Any Size | 52 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Polyp, Any Size | 212 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Polyp, < 6 mm | 188 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Polyp, >= 6 mm | 87 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Polyp, >= 10 mm | 50 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Adenoma, >= 6 mm | 71 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Adenoma, >= 10 mm | 45 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Advanced Adenoma, >= 6 mm | 49 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Advanced Adenoma, >= 10 mm | 45 participants |
| PillCam COLON | Number of Participants With Indicated Lesions Detected by Standard Colonoscopy | Colorectal Cancer | 19 participants |
Primary
Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies
The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PillCam COLON | Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies | 322 participants |
| Standard Colonoscopy | Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies | 326 participants |
Primary
Sensitivity of Capsule Endoscopy for Indicated Lesions
Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.
Time frame: 1 day
Population: Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Polyp, < 6 mm (n=188) | 61 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Polyp, Any Size (n=212) | 72 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Polyp, >= 6 mm (n=87) | 64 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Polyp, >= 10 mm (n=50) | 60 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Adenoma, >= 6 mm (n=71) | 68 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Adenoma, >= 10 mm (n=45) | 64 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Advanced Adenoma, Any Size (n=52) | 85 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Advanced Adenoma, >= 6 mm (n=49) | 73 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Advanced Adenoma, >= 10 mm (n=45) | 64 Percentage of Participants |
| PillCam COLON | Sensitivity of Capsule Endoscopy for Indicated Lesions | Colorectal Cancer (n=19) | 74 Percentage of Participants |
Primary
Specificity of Capsule Endoscopy for Indicated Lesions
Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.
Time frame: 1 day
Population: Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Polyp, Any Size (n=108) | 78 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Polyp, < 6 mm (n=132) | 82 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Polyp, >= 6 mm (n=233) | 84 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Polyp, >= 10 mm (n=270) | 98 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Adenoma, >= 6 mm (n=249) | 82 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Adenoma, >= 10 mm (n=275) | 97 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Advanced Adenoma, Any Size (n=268) | 50 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Advanced Adenoma, >= 6 mm (n=271) | 79 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Advanced Adenoma, >= 10 mm (n=275) | 97 Percentage of Participants |
| PillCam COLON | Specificity of Capsule Endoscopy for Indicated Lesions | Colorectal Cancer (n=301) | 74 Percentage of Participants |
Secondary
Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy
Time frame: within 7 days
Secondary
Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)
Time frame: within 7 days
Secondary
Number, Type and Severity of Adverse Events
Time frame: Within 7 days
Secondary
Percentage of Excreted Colon Capsules
Time frame: Within 7 days
Secondary
Percent of Participants With Scoring Index 3 or 4
Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: 1. poor cleansing level (Large amount of fecal residue.) 2. fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.) 3. good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.) 4. excellent cleansing level (No more than small bits of adherent feces.)
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PillCam COLON | Percent of Participants With Scoring Index 3 or 4 | 72 Percentage of Participants |
| Standard Colonoscopy | Percent of Participants With Scoring Index 3 or 4 | 87 Percentage of Participants |