Crohn's Disease
Conditions
Keywords
All subjects will have evidence of active symptoms associated with Crohn's disease
Brief summary
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
Detailed description
This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below: Visit 1; Screening visit * Informed consent process * screening for eligibility to participate in the study * Inclusion/exclusion criteria * Small bowel patency test * Demographic data * Pregnancy test * General medical history Visit 2; PillCam® Crohn's capsule ingestion * PillCam® CD bowel preparation * Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours) * Ileocolonoscopy with intubation of terminal ileum Follow up period (5-9 days following visit 2) • CE Follow up telephone contac
Interventions
OTHERPillcam colon capsule and PillCam™ Prep Procedure
PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
DEVICEIleocolonoscopy
Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure • Ileocolonoscopy with intubation of terminal ileum
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject ages 18-75 years, inclusive 2. Subject has known CD and signs and symptoms of active disease including one of the following: * Chronic diarrhea * Chronic abdominal pain * Rectal bleeding 3. Subject has at least one of the following within three months of enrollment: * Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin) * Anemia (hemoglobin level below normal reference range) * Hypoalbuminemia (albumin below normal reference range) * Weight loss 4. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 90 days prior to enrollment. 5. Subject agrees to sign consent form
Exclusion criteria
1. Indeterminate Colitis 2. Ulcerative Colitis 3. Antibiotic Associated Colitis 4. Stool positive for Ova &Parasite and for Clostridium difficile toxin within 3 months of enrollment 5. Other known infectious cause of increased symptoms 6. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment. 7. Definite long stricture seen on radiological exam. 8. Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) 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 has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. 11. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. 12. Subjects with known or suspected delayed gastric emptying 13. Subjects with known or suspected delayed Small bowel motility 14. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions. 15. Subject has Type I or Type II Diabetes. 16. Subject has any allergy or other known contraindication to the medications used in the study. 17. Subject has any condition, which precludes compliance with study and/or device instructions. 18. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception. 19. Concurrent participation in another clinical trial using any investigational drug or device. 20. Subject suffers from a life threatening condition. 21. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon | All the end points and outcomes measures will be evaluated within 4 months from end of enrollment | the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy. The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy. Each patient was classified as follows: * Active Crohn's disease is likely * Active Crohn's disease is NOT likely Active Crohn's disease included the followings lesions: * Aphthous ulceration * Ulcers (other than Aphthous) * Bleeding * Inflammatory stricture Lesions other than the above list were classified as Non active Crohn's disease. |
Countries
United States
Participant flow
Pre-assignment details
total of 39 cases have been excluded and were not enrolled to the study due to the follwoings: 38 cases are screen faliure 1 case due to physican decision - the patient not eligible for the study
Participants by arm
| Arm | Count |
|---|---|
| Bowel Prep Regimen Each study subject will undergo a bowel preparation followed by a PillCam procedure.
Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure
• Ileocolonoscopy with intubation of terminal ileum | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | incomplete study procedure | 5 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Bowel Prep Regimen |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants |
| Age, Continuous | 36.94 years STANDARD_DEVIATION 12.71 |
| Region of Enrollment Israel | 13 participants |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 66 |
| serious Total, serious adverse events | 3 / 66 |
Outcome results
Primary
Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon
the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy. The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy. Each patient was classified as follows: * Active Crohn's disease is likely * Active Crohn's disease is NOT likely Active Crohn's disease included the followings lesions: * Aphthous ulceration * Ulcers (other than Aphthous) * Bleeding * Inflammatory stricture Lesions other than the above list were classified as Non active Crohn's disease.
Time frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment
Population: subjects with symptoms associated with Crohn's disease
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| # Casesclassified as Active CD is Likely by CE | Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon | 55 number of subjects |
| # Casesclassified as Active CD is Likely by IC | Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon | 46 number of subjects |