Known Crohn Disease Subjects Clinical Trial
Official title:
Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
| Verified date | August 2016 |
| Source | Medtronic - MITG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure
| Status | Completed |
| Enrollment | 74 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 75 Years |
| Eligibility |
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, 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 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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| United States | Children's Center for Digestive Healthcare | Atlanta | Georgia |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | UNC Chapel Hill | Chapel Hill | North Carolina |
| United States | Gastroenterology Associates of Tidewater | Chesapeak | Virginia |
| United States | Metropolitan Gastroenterology Group | Chevy Chase | Maryland |
| United States | The University of Chicago | Chicago | Illinois |
| United States | Iowa Digestive Disease Center | Clive | Iowa |
| United States | Dr. Romeo, Dayton Gastroenterology | Dayton | Ohio |
| United States | Indiana Unveresity Hospital | Indianapolis | Indiana |
| United States | Borland-Groover Clinic | Jacksonville | Florida |
| United States | Cedars Sinai Medical Center | LA | California |
| United States | Digestive Health Center of Michigan | Michigan | Michigan |
| United States | Atlantic Health System Morristown Memorial Pediatric GE | Morristown | New Jersey |
| United States | Mayo Clinic | Scottsdale, AZ | Arizona |
| United States | Shafran Gastroenterology Center | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic - MITG |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mucosal change in VCE mucosal scores and PGA | To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure | 6 months | No |
| Secondary | correlation between SES CD score and capsule scoring indexes | Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI at baseline. | 6 months | No |
| 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 | 6 months | No |
| 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) | 6 months | No |
| Secondary | safety related to capsule | To assess safety related to capsule retention and other adverse events | 6 months | Yes |