Trial Outcomes & Findings for PillCam® Platform With the PillCam Crohn's Disease Capsule (NCT NCT01631435)

Last Updated: 2019-08-01

Results Overview

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."

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

75 participants

Primary outcome timeframe

All the end points and outcomes measures will be evaluated within 4 months from end of enrollment

Results posted on

2019-08-01

Participant Flow

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

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	75
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2
Overall Study incomplete study procedure	5

Baseline Characteristics

PillCam® Platform With the PillCam Crohn's Disease Capsule

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bowel Prep Regimen n=66 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	36.94 years STANDARD_DEVIATION 12.71 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants
Region of Enrollment Israel	13 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	# Casesclassified as "Active CD is Likely" by CE n=66 Participants The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the CD capsule endoscopy(CE). "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."	# Casesclassified as "Active CD is Likely" by IC n=66 Participants The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the Ileo colonoscopy (IC) procedure. "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."
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	46 number of subjects

Adverse Events

Bowel Prep Regimen

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bowel Prep Regimen n=66 participants at risk 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
Gastrointestinal disorders Bowel preparation	1.5% 1/66 • Number of events 1
Gastrointestinal disorders CE Proceudre	1.5% 1/66 • Number of events 1
Gastrointestinal disorders patency capsule	1.5% 1/66 • Number of events 1

Other adverse events

Other adverse events
Measure	Bowel Prep Regimen n=66 participants at risk 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
Gastrointestinal disorders nausea duo to colon preparation	100.0% 11/11 • Number of events 11
Gastrointestinal disorders vomiting due to colon preparation	9.1% 6/66 • Number of events 6
Gastrointestinal disorders mild headache due to colon preparation	1.5% 1/66 • Number of events 1
Gastrointestinal disorders mild abdominal cramping	1.5% 1/66 • Number of events 1

Additional Information

Ravit Peled , Clinical trials manager

Given Imaging- Covidien

Phone: +972 (4) 909-7894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place