Trial Outcomes & Findings for Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon (NCT NCT01372878)

Results Overview

Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard. Sensitivity measures the proportion of actual positives which are correctly identified as such. Specificity measures the proportion of negatives which are correctly identified as such. positive event defined as patients with polyps ≥6 mm detected by OC procedure.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

884 participants

Primary outcome timeframe

1 year, same as study duration

Results posted on

2019-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison
Overall Study STARTED	884
Overall Study COMPLETED	700
Overall Study NOT COMPLETED	184

Reasons for withdrawal

Reasons for withdrawal
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison
Overall Study Withdrawal by Subject	63
Overall Study Protocol Violation	17
Overall Study incomplete study procedure	104

Baseline Characteristics

Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy n=884 Participants Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison
Age, Continuous	57.29 years STANDARD_DEVIATION 5.84 • n=113 Participants
Sex: Female, Male Female	487 Participants n=113 Participants
Sex: Female, Male Male	397 Participants n=113 Participants
Region of Enrollment United States	558 participants n=113 Participants
Region of Enrollment Israel	326 participants n=113 Participants

PRIMARY outcome

Timeframe: 1 year, same as study duration

Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard. Sensitivity measures the proportion of actual positives which are correctly identified as such. Specificity measures the proportion of negatives which are correctly identified as such. positive event defined as patients with polyps ≥6 mm detected by OC procedure.

Outcome measures

Outcome measures
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy n=700 Participants Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference sensitivity of patients with Polyp>= 6 mm	69 percentage of participants Interval 63.0 to 74.0
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference specificty of patients with Polyp>= 6 mm	87 percentage of participants Interval 85.0 to 89.0

SECONDARY outcome

Timeframe: 1 year, same as study duration

Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.

Outcome measures

Outcome measures
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy n=700 Participants Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference sensitivity of patients with Polyp>= 10 mm	64 percentage of participants Interval 55.0 to 73.0
Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference specificity of patients with Polyp>= 10 mm	95 percentage of participants Interval 94.0 to 96.0

Adverse Events

Colon Capsule Endoscopy, Then Standard Colonoscopy

Serious events: 1 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy n=884 participants at risk Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison
Gastrointestinal disorders abdominal pain related to OC procedure	0.11% 1/884 • Number of events 1

Other adverse events

Other adverse events
Measure	Colon Capsule Endoscopy, Then Standard Colonoscopy n=884 participants at risk Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as "gold standard" comparison
Gastrointestinal disorders Adverse event related to preperation	11.4% 101/884 • Number of events 128
Gastrointestinal disorders Adverse event related to Capsule endoscopy	0.34% 3/884 • Number of events 3
Gastrointestinal disorders Adverse event related to Colonoscopy	0.68% 6/884 • Number of events 11

Additional Information

Ravit Peled | Biostatistics and Data Management Manager

Given Imaging

Phone: +972 (4) 909-7894

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place