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This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure
This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months .
Up to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\or adult subjects with known Crohn's disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsule endoscopy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsule endoscopy and Ileocolonoscopy tests | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) | To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff | 6 months changefrom Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes | Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline. SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific |
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Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Leighton, MD | Mayo Clinic | Principal Investigator |
| Gil Melmed, MD | Cyder Cinai LA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | United States | |||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30086261 | Derived | Melmed GY, Dubinsky MC, Rubin DT, Fleisher M, Pasha SF, Sakuraba A, Tiongco F, Shafran I, Fernandez-Urien I, Rosa B, Papageorgiou NP, Leighton JA. Utility of video capsule endoscopy for longitudinal monitoring of Crohn's disease activity in the small bowel: a prospective study. Gastrointest Endosc. 2018 Dec;88(6):947-955.e2. doi: 10.1016/j.gie.2018.07.035. Epub 2018 Aug 4. |
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recruitment started on September 2013 and ended on July 2016 74 subjects enrolled within 15 sites in the US
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| ID | Title | Description |
|---|---|---|
| FG000 | Capsule Endoscopy | Capsule endoscopy and Ileocolonoscopy tests |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline |
| Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum | Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff | 6 months change from Baseline |
| Evaluate the Entire SB CE Scores | Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS). Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific | 6 months change from Baseline |
| Adverse Events (AE) | To assess safety related to capsule retention and other adverse events | 6 months |
| Los Angeles |
| California |
| United States |
| Borland-Groover Clinic | Jacksonville | Florida | United States |
| Shafran Gastroenterology Center | Winter Park | Florida | United States |
| Children's Center for Digestive Healthcare | Atlanta | Georgia | United States |
| The University of Chicago | Chicago | Illinois | United States |
| Indiana Unveresity Hospital | Indianapolis | Indiana | United States |
| Iowa Digestive Disease Center | Clive | Iowa | United States |
| University of Maryland Medical Center | Baltimore | Maryland | United States |
| Metropolitan Gastroenterology Group | Chevy Chase | Maryland | United States |
| Digestive Health Center of Michigan | Michigan | Michigan | United States |
| Atlantic Health System Morristown Memorial Pediatric GE | Morristown | New Jersey | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | United States |
| Dr. Romeo, Dayton Gastroenterology | Dayton | Ohio | 45440 | United States |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | United States |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Capsule Endoscopy | Capsule endoscopy and Ileocolonoscopy tests |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | No |
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| 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 | Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) | To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff | Correlation between changes in VCE mucosal scores (Lewis and CECDEIS) and change in PGA score of CD (Crohn's Disease) activity from baseline to follow-up at 6 months; number of participants for this outcome measure includes participants with available data for PGA, SB (small bowel) Lewis score, SB CECDEIS score, respectively | Posted | Mean | Standard Deviation | units on a scale | 6 months changefrom Baseline |
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| Secondary | Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes | Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline. SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific | number of participants for this outcome measure includes participants with available data for SES CD, TI Lewis score, TI CECDEIS score, respectively | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum | Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff | number of subjects with Colonoscopy score is lower than number of subjects analyzed due to colonoscopy video malfunction. number of participants for this outcome measure includes participants with available data for TI SES CD, TI Lewis, TI CECDEIS scores, respectively | Posted | Mean | Standard Deviation | units on a scale | 6 months change from Baseline |
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| Secondary | Evaluate the Entire SB CE Scores | Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS). Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific | number of Lewis & CECDEIS TI score change is lower due to inability to identify TI. number of participants for this outcome measure includes participants with available data for total SB Lewis score change, TI Lewis score change, Total CECDEIS score change, TI Lewis score change, respectively | Posted | Mean | Standard Deviation | units on a scale | 6 months change from Baseline |
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| Secondary | Adverse Events (AE) | To assess safety related to capsule retention and other adverse events | all enrolled subjects | Posted | Number | AE incidents | 6 months |
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Adverse events data collected from subject enrollment up to end of study
all adverse events identified on study subjects were collected from patient enrollment up to end of study duration: AE related and not related to study procedure and or product as well as anticipated and unanticipated AEs
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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 | Capsule Endoscopy | Capsule endoscopy and Ileocolonoscopy tests | 3 | 74 | 24 | 74 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of IBD, Nausea, vomiting, diarrhea, abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | Unanticipated serious adverse event not related to study device |
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| Asthma Excerbation, Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Unanticipated serious adverse event not related to study device |
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| Pancreatitis, Acute | Hepatobiliary disorders | Non-systematic Assessment | Unanticipated serious adverse event not related to study device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment | non-serious AE |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | non-serious AE |
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| Athralgia Of Hands And Elbows, Arthritis Flare | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | non-serious AE |
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| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | non-serious AE |
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| Bilateral Bursitis In Hips | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | non-serious AE |
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| Blolating | Gastrointestinal disorders | Non-systematic Assessment | non-serious AE |
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| Bruise At Venipucture Site. Right Anticubital Space | Injury, poisoning and procedural complications | Non-systematic Assessment | non-serious AE |
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| Bruised Coccyx Due To Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | non-serious AE |
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| C-Difficile | Gastrointestinal disorders | Non-systematic Assessment | non-serious AE |
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| Chest Pain | Cardiac disorders | Non-systematic Assessment | non-serious ae |
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| Common Cold, cough | Infections and infestations | Non-systematic Assessment | non-serious |
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| Crohn's Flare | Gastrointestinal disorders | Non-systematic Assessment | non-serious AE |
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| Cyst Right Great Toe | Injury, poisoning and procedural complications | Non-systematic Assessment | non-serious AE |
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| Detached Retina | Eye disorders | Non-systematic Assessment | non-serious |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | non-serious |
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| Fatigue | General disorders | Non-systematic Assessment | non-serious |
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| fell | Injury, poisoning and procedural complications | Non-systematic Assessment | non-serious |
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| Flu | Infections and infestations | Non-systematic Assessment | non-serious |
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| Heartburn | Cardiac disorders | Non-systematic Assessment | non-serious AE |
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| Hyponatremia | Injury, poisoning and procedural complications | Non-systematic Assessment | non-serious AE |
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| Incontinence a Little Worse And More Often | Renal and urinary disorders | Non-systematic Assessment | non-serious AE |
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| Iron Deficiency Anemia | Hepatobiliary disorders | Non-systematic Assessment | non-serious AE |
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| Joint pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | non-serious AE |
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| Light Headed | General disorders | Non-systematic Assessment | non-serious AE |
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| Mild Perianal Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | non-serious AE |
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| Nasal congestion | Infections and infestations | Non-systematic Assessment | non-serious AE |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment | non-serious AE |
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| Pulled Upper Back Muscle Left Side | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | non-serious AE |
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| Questionable Right Lower Quadrant Mass | General disorders | Non-systematic Assessment | non-serious AE |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | non-serious AE |
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| Rectal Urgency | Gastrointestinal disorders | Non-systematic Assessment | non-serious AE |
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| Respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | non-serious AE |
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| Right Leg Bruising Secondary To Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | non-serious AE |
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| Strep Throat | Infections and infestations | Non-systematic Assessment | non-serious AE |
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| Superficial Blood Clot Left Axilla Area | General disorders | Non-systematic Assessment | non-serious AE |
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| Syncope | General disorders | Non-systematic Assessment | non-serious AE |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | non-serious AE |
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| Worsening Diabetes | Metabolism and nutrition disorders | Non-systematic Assessment | non-serious AE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Manager | Medtronic | +972-4-9097952 | michal.kedar-datel@medtronic.com |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Total SB CECDEIS score change |
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| Sperman correlation |
| 0.882 |
| Sperman correlation coeficient |
| 0.022 |
| 2-Sided |
| Superiority or Other |
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| Incidence of Serious Adverse Events |
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| Incidence of Non-Serious Adverse Events |
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| Incidence of Anticipated Adverse Events |
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| Incident of Serious Unanticipated Adverse Events |
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