Trial Outcomes & Findings for Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease (NCT NCT00487396)

Results Overview

To evaluate whether capsule endoscopy (CE) prior to ileocolonoscopy (IC) improves the diagnostic yield in patients with suspected Crohn's disease when compared to IC and SBFT. McNemar test was preformed in order to evaluate the diagnostic yield of IC combined with CE as compared to the diagnostic yield of IC combined with SBFT.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

98 participants

Primary outcome timeframe

four months from enrollment

Results posted on

2020-10-22

Participant Flow

Study started on September 2007 and data collection completed on October 2010. Study conducted in 10 clinical sites (hospitals and private clinics) in the USA, Sweden, Canada and Israel

98 patients enrolled in this study. 18 cases excluded due to the following: 15 cases were excluded due to noncompliance with the protocol. 1 patient withdrew consent before any study procedure. 1 patient could not ingest the capsule. 1 patient refused to undergo the ileocolonoscopy and SBFT. Therefore 80 patients were included in the analysis

Participant milestones

Participant milestones
Measure	SB Capsule Then Standard Ileocolonoscopy Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
Overall Study STARTED	98
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SB Capsule Then Standard Ileocolonoscopy n=80 Participants Capsule endoscopy was ingested.The purpose was to detect patients with Crohn's Disease. Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
Age, Categorical <=18 years	20 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	28.35 years STANDARD_DEVIATION 13.25 • n=93 Participants
Sex: Female, Male Female	38 Participants n=93 Participants
Sex: Female, Male Male	42 Participants n=93 Participants
Region of Enrollment United States	46 participants n=93 Participants
Region of Enrollment Israel	20 participants n=93 Participants
Region of Enrollment Sweden	14 participants n=93 Participants

PRIMARY outcome

Timeframe: four months from enrollment

Population: The number of found and missed pathologies (i.e. ulcers, lesions, etc.) were calculated for the combination of procedures.

To evaluate whether capsule endoscopy (CE) prior to ileocolonoscopy (IC) improves the diagnostic yield in patients with suspected Crohn's disease when compared to IC and SBFT. McNemar test was preformed in order to evaluate the diagnostic yield of IC combined with CE as compared to the diagnostic yield of IC combined with SBFT.

Outcome measures

Outcome measures
Measure	PillCam SB Followed by Ileo Colonoscopy n=110 pathologies Ingestible capsule equipped with an endoscope with one imagers, before ileo-colonoscopy.	Small Bowel Follow Through (SBFT) and Ileo-colonoscopy n=110 pathologies Following ingestible capsule, same patients also underwent ileo-colonoscopy (IC) and small bowel follow through (SBFT).
Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT)	97.3 percentage of yield	57.3 percentage of yield

SECONDARY outcome

Timeframe: four months from enrollment

Population: The number of found and missed pathologies (i.e. ulcers, lesions, etc.) were calculated for the combination of procedures.

McNemar test was preformed in order to evaluate the diagnostic yield of PillCam SB (CE) as compared to the diagnostic yield of small bowel follow through (SBFT).

Outcome measures

Outcome measures
Measure	PillCam SB Followed by Ileo Colonoscopy n=43 pathologies Ingestible capsule equipped with an endoscope with one imagers, before ileo-colonoscopy.	Small Bowel Follow Through (SBFT) and Ileo-colonoscopy n=43 pathologies Following ingestible capsule, same patients also underwent ileo-colonoscopy (IC) and small bowel follow through (SBFT).
Diagnostic Yield (CE vs. SBFT)	93.0 percentage of yield	25.6 percentage of yield

SECONDARY outcome

Timeframe: four months from enrollment

Population: The number of found and missed pathologies (i.e. ulcers, lesions, etc.) were calculated for the combination of procedures.

McNemar test was preformed in order to evaluate the diagnostic yield of PillCam SB (CE) as compared to the diagnostic yield of ileocolonoscopy (IC).

Outcome measures

Outcome measures
Measure	PillCam SB Followed by Ileo Colonoscopy n=61 pathologies Ingestible capsule equipped with an endoscope with one imagers, before ileo-colonoscopy.	Small Bowel Follow Through (SBFT) and Ileo-colonoscopy n=61 pathologies Following ingestible capsule, same patients also underwent ileo-colonoscopy (IC) and small bowel follow through (SBFT).
Diagnostic Yield (CE vs. IC)	49.2 percentage of yield	70.5 percentage of yield

Adverse Events

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adverse Events n=80 participants at risk All subjects received both the capsule endoscopy procedure and the ileocolonoscopy procedure
Gastrointestinal disorders Capsule Retention	1.2% 1/80 • Number of events 1 • Adverse event monitoring was performed for each visit during the visit and the following 1-3 days. Participation lasted for up to 12 months.

Other adverse events

Other adverse events
Measure	Adverse Events n=80 participants at risk All subjects received both the capsule endoscopy procedure and the ileocolonoscopy procedure
General disorders Weakness	1.2% 1/80 • Number of events 1 • Adverse event monitoring was performed for each visit during the visit and the following 1-3 days. Participation lasted for up to 12 months.
Gastrointestinal disorders Abdominal Pain	2.5% 2/80 • Number of events 2 • Adverse event monitoring was performed for each visit during the visit and the following 1-3 days. Participation lasted for up to 12 months.
Gastrointestinal disorders Nausea	1.2% 1/80 • Number of events 1 • Adverse event monitoring was performed for each visit during the visit and the following 1-3 days. Participation lasted for up to 12 months.
Product Issues Capsule retention	2.5% 2/80 • Number of events 2 • Adverse event monitoring was performed for each visit during the visit and the following 1-3 days. Participation lasted for up to 12 months.
Gastrointestinal disorders Blood in stool	1.2% 1/80 • Number of events 1 • Adverse event monitoring was performed for each visit during the visit and the following 1-3 days. Participation lasted for up to 12 months.
Skin and subcutaneous tissue disorders Skin irritation	1.2% 1/80 • Number of events 1 • Adverse event monitoring was performed for each visit during the visit and the following 1-3 days. Participation lasted for up to 12 months.
General disorders dehydration	1.2% 1/80 • Number of events 1 • Adverse event monitoring was performed for each visit during the visit and the following 1-3 days. Participation lasted for up to 12 months.

Additional Information

Director, Clinical Affairs

Given Imaging

Phone: +972-4-9097777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place