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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01372878
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : May 6, 2014
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Screening
Condition CRC Screening
Interventions Device: PillCam® COLON 2 procedure
Procedure: Colonoscopy
Enrollment 884
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Colon Capsule Endoscopy, Then Standard Colonoscopy
Hide Arm/Group Description 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
Period Title: Overall Study
Started 884
Completed 700
Not Completed 184
Reason Not Completed
Withdrawal by Subject             63
Protocol Violation             17
incomplete study procedure             104
Arm/Group Title Colon Capsule Endoscopy, Then Standard Colonoscopy
Hide Arm/Group Description 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 Number of Baseline Participants 884
Hide Baseline Analysis Population Description
CRC population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 884 participants
57.29  (5.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 884 participants
Female
487
  55.1%
Male
397
  44.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 884 participants
United States 558
Israel 326
1.Primary Outcome
Title 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
Hide Description

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.

Time Frame 1 year, same as study duration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colon Capsule Endoscopy, Then Standard Colonoscopy
Hide Arm/Group Description:
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 Number of Participants Analyzed 700
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
sensitivity of patients with Polyp>= 6 mm
69
(63 to 74)
specificty of patients with Polyp>= 6 mm
87
(85 to 89)
2.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 1 year, same as study duration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Colon Capsule Endoscopy, Then Standard Colonoscopy
Hide Arm/Group Description:
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 Number of Participants Analyzed 700
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
sensitivity of patients with Polyp>= 10 mm
64
(55 to 73)
specificity of patients with Polyp>= 10 mm
95
(94 to 96)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Colon Capsule Endoscopy, Then Standard Colonoscopy
Hide Arm/Group Description 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
All-Cause Mortality
Colon Capsule Endoscopy, Then Standard Colonoscopy
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Colon Capsule Endoscopy, Then Standard Colonoscopy
Affected / at Risk (%) # Events
Total   1/884 (0.11%)    
Gastrointestinal disorders   
abdominal pain related to OC procedure [1]  1/884 (0.11%)  1
[1]
The event was resolved the following day
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Colon Capsule Endoscopy, Then Standard Colonoscopy
Affected / at Risk (%) # Events
Total   110/884 (12.44%)    
Gastrointestinal disorders   
Adverse event related to preperation [1]  101/884 (11.43%)  128
Adverse event related to Capsule endoscopy [2]  3/884 (0.34%)  3
Adverse event related to Colonoscopy [3]  6/884 (0.68%)  11
[1]
adverse events were reported as related to the colon preparation such as vomiting and nausea
[2]
Three adverse events were reported as related to the capsule procedure and resolved within the same day (i.e., severe gagging reflex, mild vomiting and abdominal cramping)
[3]
Eleven adverse events were reported as related to the colonoscopy procedure such as fever, headache, abdominal pain, bloating and nausea
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ravit Peled | Biostatistics and Data Management Manager
Organization: Given Imaging
Phone: +972 (4) 909-7894 ext 7894
EMail: ravit.peled@givenimaging.com
Layout table for additonal information
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01372878    
Other Study ID Numbers: MA-204
First Submitted: June 5, 2011
First Posted: June 14, 2011
Results First Submitted: April 2, 2014
Results First Posted: May 6, 2014
Last Update Posted: August 1, 2019