Colorectal Cancer Screening
Conditions
Keywords
Polyps, Capsule endoscopy, Bowel preparation regimen, Average risk patients for colorectal cancer screening
Brief summary
This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients. Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.
Detailed description
This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE. Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.
Interventions
DEVICEPillCam® COLON 2 procedure-CONTROL
DRUGSenna tablets
DRUGPEG
DRUGMetoclopramide
DRUGErythromycin
DRUGSUPREP oral sulfate solution
DRUGBisacodyl
DRUGSUPREP oral sulfate solution with Gastrografin
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subject is between 50 and 75 years of age. 2. Subject is classified as average risk per the American Gastroenterological Association Guidelines on Colorectal Cancer Screening: Individuals without a personal or family history of colorectal cancer (CRC) or adenomas, inflammatory bowel disease, or high-risk genetic syndromes. 3. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent.
Exclusion criteria
1. Subject with history of polyps (including those identified by computed tomography \[CT\], optical colonoscopy, sigmoidoscopy, etc.). 2. Subject with history of negative colon assessment (including CT, optical colonoscopy, sigmoidoscopy etc.) within 5 years as these subjects would be defined not requiring screening in this time frame. 3. Subject with suspected or diagnosed with hematochezia, melena, iron deficiency with or without anemia, or any other rectal bleeding, including positive fecal occult blood test of any variety. 4. Subject with any condition believed to have an increased risk of capsule retention such as suspected or known bowel obstruction, stricture, or fistula. 5. Subject with dysphagia or any swallowing disorder. 6. Subject with serious medical conditions that would increase the risk associated with capsule or colonoscopy that are so severe that screening would have no benefit. 7. Subject with a cardiac pacemaker or other implanted electromedical device. 8. Subject expected to undergo MRI examination within 7 days after ingestion of the capsule. 9. Subject with clinical evidence of renal disease, including clinically significant laboratory abnormalities of renal function within the past 6 months, or at any time in the past if not tested within the last 6 months, defined as creatinine, blood urea nitrogen (BUN), and/or glomerular filtration rate (GFR) outside of the local laboratory reference range. 10. Subject with known gastrointestinal motility disorders. 11. Subject with allergies or known contraindication to the medications or preparation agents used in the procedure as described in the relevant instructions for use. 12. Subject with comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months. 13. Subject is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity). 14. Subject is pregnant, suspected pregnant, or is actively breast-feeding. Females of child-bearing potential will be required to provide either a urine pregnancy test or serum pregnancy test as part of the participant's standard of care regardless of their participation in the study (except for subjects who are surgically sterile or are post-menopausal for at least two years). 15. Subject has participated in an investigational drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Within two weeks of study procedure | The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Will be assessed from RAPID video in total and by segment |
| Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment |
| Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Will be assessed from RAPID video in total and by segment |
| Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Will be assesses by applicable case report form (CRF) |
| Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE | Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day. | Will be assesses by applicable CRF |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bowel Preparation Regimen -Control Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-CONTROL
Senna tablets
PEG
Metoclopramide
Erythromycin
SUPREP oral sulfate solution
Bisacodyl | 60 |
| Bowel Preparation Regimen-Test Regimen includes administration of:
Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.
PillCam® COLON 2 procedure-Test
Senna tablets
PEG
Metoclopramide
Erythromycin
Bisacodyl
SUPREP oral sulfate solution with Gastrografin | 62 |
| Total | 122 |
Baseline characteristics
| Characteristic | Bowel Preparation Regimen-Test | Bowel Preparation Regimen -Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 2 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 58 Participants | 114 Participants |
| Age, Continuous | 53 years | 53 years | 53 years |
| Region of Enrollment United States | 62 participants | 60 participants | 122 participants |
| Sex: Female, Male Female | 34 Participants | 31 Participants | 65 Participants |
| Sex: Female, Male Male | 28 Participants | 29 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 59 | 12 / 62 |
| serious Total, serious adverse events | 0 / 59 | 1 / 62 |
Outcome results
Primary
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).
Time frame: Within two weeks of study procedure
Population: this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Overall Good cleansing | 70.5 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Cecum Excellent cleansing | 14.0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Ascending Excellent cleansing | 12.2 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Transverse Excellent cleansing | 10.6 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Descending Excellent cleansing | 9.5 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Rectum Excellent cleansing | 0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Overall Excellent cleansing | 6.8 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Cecum Good cleansing | 54.0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Ascending Good cleansing | 63.3 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Transverse Good cleansing | 61.7 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Descending Good cleansing | 73.8 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Rectum Good cleansing | 56.1 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Overall Fair cleansing | 22.7 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Cecum Fair cleansing | 30.0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Ascending Fair cleansing | 22.5 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Transverse Fair cleansing | 27.7 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Descending Fair cleansing | 16.7 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Rectum Fair cleansing | 46.5 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Overall Poor cleansing | 0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Cecum Poor cleansing | 2.0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Ascending Poor cleansing | 2.0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Transverse Poor cleansing | 0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Descending Poor cleansing | 0 percentage of particpants |
| Bowel Preparation Regimen -Control | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Rectum Poor cleansing | 2.4 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Descending Poor cleansing | 0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Overall Excellent cleansing | 16.7 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Overall Fair cleansing | 24.1 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Cecum Excellent cleansing | 14.6 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Overall Poor cleansing | 0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Ascending Excellent cleansing | 18.2 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Cecum Fair cleansing | 30.9 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Transverse Excellent cleansing | 14.6 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Transverse Poor cleansing | 0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Descending Excellent cleansing | 18.5 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Ascending Fair cleansing | 21.8 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Rectum Excellent cleansing | 10.0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Cecum Poor cleansing | 1.8 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Overall Good cleansing | 59.3 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Transverse Fair cleansing | 25.5 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Cecum Good cleansing | 52.7 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Rectum Poor cleansing | 2.0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Ascending Good cleansing | 60.0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Descending Fair cleansing | 18.5 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Transverse Good cleansing | 60.0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Ascending Poor cleansing | 0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Descending Good cleansing | 63.0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Rectum Fair cleansing | 36.0 percentage of particpants |
| Bowel Preparation Regimen-Test | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Rectum Good cleansing | 52.0 percentage of particpants |
Secondary
Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE
Will be assesses by applicable CRF
Time frame: Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bowel Preparation Regimen -Control | Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE | 3.4 percentage of participants with >1 AE |
| Bowel Preparation Regimen-Test | Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE | 19.4 percentage of participants with >1 AE |
Secondary
Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE
Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment
Time frame: an expected average of 3 weeks from study procedure
Population: The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bowel Preparation Regimen -Control | Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE | 2.8 hours |
| Bowel Preparation Regimen-Test | Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE | 2.4 hours |
Secondary
Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE
Will be assessed from RAPID video in total and by segment
Time frame: an expected average of 3 weeks from study procedure
Population: Per protocol analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bowel Preparation Regimen -Control | Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE | 76.9 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE | 90.9 percentage of participants |
Secondary
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Will be assessed from RAPID video in total and by segment
Time frame: an expected average of 3 weeks from study procedure
Population: This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Overall (any size) | 46.8 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Cecum (any size) | 6.0 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Ascending (any size) | 14.0 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Transverse (any size) | 4.3 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Descending (any size) | 31.9 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | rectum (any size) | 24.4 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Overall (polyps ≥6mm) | 21.3 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Cecum (polyps ≥6mm) | 2.0 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Ascending (polyps ≥6mm) | 2.0 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Transverse (polyps ≥6mm) | 4.3 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Descending (polyps ≥6mm) | 12.8 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Rectum (polyps ≥6mm) | 7.3 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Overall (polyps ≥10mm) | 8.5 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Cecum Overall (polyps ≥10mm) | 0 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Ascending Overall (polyps ≥10mm) | 2.0 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Transverse (polyps ≥10mm) | 0 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Descending (polyps ≥10mm) | 4.3 percentage of participants |
| Bowel Preparation Regimen -Control | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Rectum (polyps ≥10mm) | 4.9 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Cecum Overall (polyps ≥10mm) | 7.3 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Overall (any size) | 58.2 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Transverse (polyps ≥6mm) | 7.3 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Cecum (any size) | 14.6 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Rectum (polyps ≥10mm) | 2.0 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Ascending (any size) | 9.1 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Descending (polyps ≥6mm) | 16.4 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Transverse (any size) | 7.3 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Ascending Overall (polyps ≥10mm) | 3.6 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Descending (any size) | 29.1 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Rectum (polyps ≥6mm) | 6.0 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | rectum (any size) | 32.0 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Descending (polyps ≥10mm) | 3.6 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Overall (polyps ≥6mm) | 36.4 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Overall (polyps ≥10mm) | 14.6 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Cecum (polyps ≥6mm) | 12.7 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Transverse (polyps ≥10mm) | 1.8 percentage of participants |
| Bowel Preparation Regimen-Test | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Ascending (polyps ≥6mm) | 3.6 percentage of participants |
Secondary
Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE
Will be assesses by applicable case report form (CRF)
Time frame: an expected average of 3 weeks from study procedure
Population: PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake \<1h and \> 2.15h, Morning PEG intake \<1h and \>2:15 h, Capsule ingestion l\<45 min or \>75 min after PEG intake , Overall PEG intake volume is less than 3 liters
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bowel Preparation Regimen -Control | Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE | 80.4 percentage of participants |
| Bowel Preparation Regimen-Test | Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE | 90.9 percentage of participants |