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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bowel preparation regimen -Control | Active Comparator | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (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. |
|
| Bowel preparation regimen-Test | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam® COLON 2 procedure-CONTROL | Device |
| ||
| Senna tablets |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Within two weeks of study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | Will be assessed from RAPID video in total and by segment | an expected average of 3 weeks from study procedure |
| Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas K Rex, Dr. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Indiana University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bowel Preparation Regimen -Control | Regimen includes administration of: Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| PEG | Drug |
|
| Metoclopramide | Drug |
|
| Erythromycin | Drug |
|
| SUPREP oral sulfate solution | Drug |
|
| Bisacodyl | Drug |
|
| SUPREP oral sulfate solution with Gastrografin | Drug |
|
Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment |
| an expected average of 3 weeks from study procedure |
| 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 | an expected average of 3 weeks from study procedure |
| 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) | an expected average of 3 weeks from study procedure |
| Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE | Will be assesses by applicable CRF | Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day. |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Indianapolis Gastroenterology and Hepatology | Indianapolis | Indiana | 46237 | United States |
| Dayton Gastroenterology | Dayton | Ohio | 45440 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Franklin Gastroenterology, PLLC | Franklin | Tennessee | 37067 | United States |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon. | Posted | Number | percentage of particpants | Within two weeks of study procedure |
|
|
| ||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Number | percentage of participants | an expected average of 3 weeks from study procedure |
| ||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Median | Full Range | hours | an expected average of 3 weeks from study procedure |
| |||||||||||||||||||||||||||||||||||||
| 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 | Per protocol analysis set | Posted | Number | percentage of participants | an expected average of 3 weeks from study procedure |
| ||||||||||||||||||||||||||||||||||||||
| 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) | 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 | Posted | Number | percentage of participants | an expected average of 3 weeks from study procedure |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE | Will be assesses by applicable CRF | Full analysis set | Posted | Number | percentage of participants with >1 AE | Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day. |
|
Adverse Events (AE) were collected starting from the screening visit and until 5-9 following the PillCam procedure day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 59 | 2 | 59 | ||
| EG001 | 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 | 1 | 62 | 12 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Sinusitis | Eye disorders | MedDRA 17.0 | Systematic Assessment | Subject experienced double vision and swollen eye and was hospitalized. He was scheduled to undergo Functional Endonasal sinus surgery. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Irritation | General disorders | MedDRA 17.0 | Systematic Assessment | Skin irritation |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment | Muscle strain |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Dyspesia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Haedache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| Eye swelling | Ear and labyrinth disorders | MedDRA 17.0 | Systematic Assessment |
|
Prior written consent is required for PI to independently publish any study results before a multi-center publication is released. If a multi-center manuscript is not submitted for publication within 1 year after completion of the Trial, PI shall have the right to Publish results. Sponsor shall respond within 45 days and shall have the right to delay the Publication for an additional 90.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liron Bar Yaakov | Given Imaging (a Medtronic company) | +97249097946 | liron.bar-yaakov@covidien.com |
| ID | Term |
|---|---|
| D011127 | Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000081226 | Sennosides |
| D008787 | Metoclopramide |
| D004917 | Erythromycin |
| D001726 | Bisacodyl |
| D003974 | Diatrizoate Meglumine |
| ID | Term |
|---|---|
| D012676 | Senna Extract |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001549 | Benzamides |
| D000577 | Amides |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D003408 | Cresols |
| D008536 | Meglumine |
| D013012 | Sorbitol |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D003973 | Diatrizoate |
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
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| >=65 years |
|
| Male |
|
| Ascending Excellent cleansing |
|
| Transverse Excellent cleansing |
|
| Descending Excellent cleansing |
|
| Rectum Excellent cleansing |
|
| Overall Good cleansing |
|
| Cecum Good cleansing |
|
| Ascending Good cleansing |
|
| Transverse Good cleansing |
|
| Descending Good cleansing |
|
| Rectum Good cleansing |
|
| Overall Fair cleansing |
|
| Cecum Fair cleansing |
|
| Ascending Fair cleansing |
|
| Transverse Fair cleansing |
|
| Descending Fair cleansing |
|
| Rectum Fair cleansing |
|
| Overall Poor cleansing |
|
| Cecum Poor cleansing |
|
| Ascending Poor cleansing |
|
| Transverse Poor cleansing |
|
| Descending Poor cleansing |
|
| Rectum Poor cleansing |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
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| Units | Counts |
|---|---|
| Participants |
|
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