Known Crohn Disease Subjects
Conditions
Brief summary
This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure
Detailed description
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
Interventions
DEVICECapsule endoscopy and Ileocolonoscopy tests
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject ages 2-75 years, inclusive 2. Subjects with a diagnosis of known Crohn disease 3. Referred to ileocolonoscopy (up to 4 weeks before the CE procedure) 4. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment. 5. Subject or parent agrees to sign consent form
Exclusion criteria
The presence of any of the following will exclude a subject from study enrollment: 1. Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE 2. Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy 3. Stricture seen on radiological exam. 4. Indeterminate Colitis 5. Ulcerative Colitis 6. Antibiotic Associated Colitis 7. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment. 8. Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment 9. Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract. 10. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. 11. Subjects with known or suspected delayed gastric emptying 12. Subjects with known or suspected delayed Small bowel motility 13. Subject has any allergy or other known contraindication to the medications used in the study. 14. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception. 15. Unwillingness to use a medically accepted method of contraception throughout duration of study 16. Concurrent participation in another clinical trial using any investigational drug or device. 17. Subject has cardiac pacemaker or other implanted electromedical devices 18. Subject suffers from a life threatening condition. 19. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters. 20. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) | 6 months changefrom Baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes | Baseline | 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 |
| Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum | 6 months change from Baseline | 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 |
| Evaluate the Entire SB CE Scores | 6 months change from Baseline | 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 |
| Adverse Events (AE) | 6 months | To assess safety related to capsule retention and other adverse events |
Countries
United States
Participant flow
Recruitment details
recruitment started on September 2013 and ended on July 2016 74 subjects enrolled within 15 sites in the US
Participants by arm
| Arm | Count |
|---|---|
| Capsule Endoscopy Capsule endoscopy and Ileocolonoscopy tests | 74 |
| Total | 74 |
Baseline characteristics
| Characteristic | Capsule Endoscopy |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Age, Continuous | 37.3 years STANDARD_DEVIATION 13.92 |
| Region of Enrollment United States | 74 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 24 / 74 |
| serious Total, serious adverse events | 3 / 74 |
Outcome results
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
Time frame: 6 months changefrom Baseline
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Capsule Endoscopy | Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) | Total SB CECDEIS score change | -2.7 units on a scale | Standard Deviation 9.05 |
| Capsule Endoscopy | Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) | PGA score change | -0.3 units on a scale | Standard Deviation 0.77 |
| Capsule Endoscopy | Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment) | Total SB Lewis score | -382.9 units on a scale | Standard Deviation 1232.8 |
Comparison: Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-upp-value: 0.631Sperman test
Comparison: Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-upp-value: 0.882Sperman correlation
Secondary
Adverse Events (AE)
To assess safety related to capsule retention and other adverse events
Time frame: 6 months
Population: all enrolled subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Capsule Endoscopy | Adverse Events (AE) | Incidence of Serious Adverse Events | 5 AE incidents |
| Capsule Endoscopy | Adverse Events (AE) | Incidence of Non-Serious Adverse Events | 59 AE incidents |
| Capsule Endoscopy | Adverse Events (AE) | Incidence of Anticipated Adverse Events | 0 AE incidents |
| Capsule Endoscopy | Adverse Events (AE) | Incident of Serious Unanticipated Adverse Events | 5 AE incidents |
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
Time frame: Baseline
Population: number of participants for this outcome measure includes participants with available data for SES CD, TI Lewis score, TI CECDEIS score, respectively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Capsule Endoscopy | Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes | TI SES-CD score at baseline visit | 3.2 units on a scale | Standard Deviation 3.62 |
| Capsule Endoscopy | Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes | TI Lewis score at baseline | 11941.1 units on a scale | Standard Deviation 1874.7 |
| Capsule Endoscopy | Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes | TI CECDEIS score at baseline | 14 units on a scale | Standard Deviation 15.51 |
Comparison: Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visitp-value: <0.001Sperman correlation
Comparison: Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visitp-value: <0.001Sperman correlation
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
Time frame: 6 months change from Baseline
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Capsule Endoscopy | Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum | TI SES-CD score change | -0.4 units on a scale | Standard Deviation 2.88 |
| Capsule Endoscopy | Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum | TI Lewis score change | -410.8 units on a scale | Standard Deviation 1266.9 |
| Capsule Endoscopy | Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum | TI CECDEIS score change | -3.1 units on a scale | Standard Deviation 11.55 |
Comparison: Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-upp-value: 0.002Sperman correlation
Comparison: Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-upp-value: <0.001Sperman correlation
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
Time frame: 6 months change from Baseline
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Capsule Endoscopy | Evaluate the Entire SB CE Scores | Total SB CECDEIS score change | -2.7 units on a scale | Standard Deviation 9.05 |
| Capsule Endoscopy | Evaluate the Entire SB CE Scores | TI CECDEIS score change | -3.1 units on a scale | Standard Deviation 11.55 |
| Capsule Endoscopy | Evaluate the Entire SB CE Scores | total SB Lewis score change | -382.9 units on a scale | Standard Deviation 1232.8 |
| Capsule Endoscopy | Evaluate the Entire SB CE Scores | TI Lewis score change | -410.8 units on a scale | Standard Deviation 1266.9 |
Comparison: Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-upp-value: <0.001Sperman correlation
Comparison: Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-upp-value: <0.001Sperman correlation