Trial Outcomes & Findings for Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon (NCT NCT01269372)

Results Overview

PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Up to 6 weeks

Results posted on

2020-10-01

Participant Flow

Participant milestones

Participant milestones
Measure	Reporting Group This was a single center study where 30 patients were enrolled. No formal sample sizing has been performed as this study was a pilot for a larger multicenter trial. All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reporting Group n=30 Participants This was a single center study where 30 patients were enrolled. No formal sample sizing has been performed as this study was a pilot for a larger multicenter trial. All subjects that were enrolled in this study were indicated and scheduled to undergo colonoscopy based on their age and demographics for screening for polyps.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	52.57 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Thirty patients were enrolled in the study.	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: The accuracy parameters were calculated per subject analysis, i.e. the accuracy events were generated by the larger polyp identified in a given subject.

PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

Outcome measures

Outcome measures
Measure	PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp n=30 Participants All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp \>= 6mm	PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp n=30 Participants All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp \>= 10mm
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity	83 percentage of sensitivity Interval 42.0 to 99.0	50 percentage of sensitivity Interval 9.0 to 91.0

PRIMARY outcome

Timeframe: Up to 6 weeks

Population: The accuracy parameters were calculated per subject analysis, i.e. the accuracy events were generated by the larger polyp identified in a given subject.

PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy in detecting subjects with polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

Outcome measures

Outcome measures
Measure	PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp n=30 Participants All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp \>= 6mm	PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp n=30 Participants All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp \>= 10mm
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Specificity	92 percentage of specificity Interval 73.0 to 99.0	100 percentage of specificity Interval 86.0 to 100.0

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: The accuracy parameters were calculated per segment analysis, i.e. the accuracy events were generated by the larger polyp identified in a given location (5 segments).

PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Sensitivity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

Outcome measures

Outcome measures
Measure	PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp n=30 Participants All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp \>= 6mm	PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp n=30 Participants All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp \>= 10mm
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Sensitivity	80 percentage of sensitivity Interval 48.0 to 95.0	33 percentage of sensitivity Interval 6.0 to 80.0

SECONDARY outcome

Timeframe: Up to 6 weeks

Population: The accuracy parameters were calculated per segment analysis, i.e. the accuracy events were generated by the larger polyp identified in a given location (5 segments).

PillCam® Colon 2 Capsule Endoscopy (CE) compared to standard colonoscopy was evaluated by clustered sensitivity for polyps equal to or larger than 6 mm and 10 mm as measured by Specificity. A positive event was defined as per optical colonoscopy polyp size measurement. Standard colonoscopy is the gold standard.

Outcome measures

Outcome measures
Measure	PillCam® Colon 2 Followed by Standard Colonoscopy - >6mm Polyp n=30 Participants All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp \>= 6mm	PillCam® Colon 2 Followed by Standard Colonoscopy 10mm Polyp n=30 Participants All subjects received PillCam Colon 2 followed by standard colonoscopy 4-6 week after CE procedure. Sensitivity is presented for the detection of subjects with polyp \>= 10mm
Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) Detecting Polyps Per Location - Specificity	96 percentage of specificity Interval 92.0 to 99.0	100 percentage of specificity Interval 97.0 to 100.0

Adverse Events

PillCam Colon 2 and Standard Colonoscopy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PillCam Colon 2 and Standard Colonoscopy n=30 participants at risk All subjects received Capsule Endoscopy (CE) using the PillCam Colon 2 followed by a standard colonoscopy.
Skin and subcutaneous tissue disorders alergic reaction to adhesive	6.7% 2/30 • Number of events 2 • Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.
Gastrointestinal disorders Globus Hystericus	3.3% 1/30 • Number of events 1 • Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.
General disorders abdominal pain	6.7% 2/30 • Number of events 2 • Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.
Gastrointestinal disorders diarrhea	3.3% 1/30 • Number of events 1 • Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.
Gastrointestinal disorders nausea	3.3% 1/30 • Number of events 2 • Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.
Gastrointestinal disorders headache	3.3% 1/30 • Number of events 1 • Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.
Gastrointestinal disorders vomiting	3.3% 1/30 • Number of events 1 • Adverse events were collected and documented until the end of Colonoscopy procedure, which was scheduled 4-6 weeks after the PillCam Colon 2 CE procedure and was the end of the study.

Additional Information

Hilla Debby/ Director of Clinical Affairs

Givenimaging

Phone: 97299077740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place