Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 3559 for:    colon cancer AND Colonic Diseases

PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon (MA-53)

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: NCT00604162
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : February 18, 2011
Last Update Posted : August 1, 2019
Sponsor:
Information provided by:
Medtronic - MITG

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Colonic Diseases
Interventions Device: PillCam COLON
Procedure: Standard colonoscopy
Enrollment 332
Recruitment Details 8 Hospital sites
Pre-assignment Details Four patients withdrew before completing the study documents and were not included in the analysis.An additional 8 patients were not included in the analysis of the accuracy of polyp detection.
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 332
Completed 328
Not Completed 4
Reason Not Completed
Physician Decision             3
Withdrawal by Subject             1
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 328
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
<=18 years
0
   0.0%
Between 18 and 65 years
227
  69.2%
>=65 years
101
  30.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 328 participants
58.5  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 328 participants
Female
147
  44.8%
Male
181
  55.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 328 participants
France 96
Spain 63
Germany 49
Italy 53
United Kingdom 20
Belgium 47
1.Primary Outcome
Title Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies
Hide Description The number of participants that completed the capsule endoscopy procedure with video images of the entire colon that could be read by a clinician, or subsequently had a full colonoscopy with visualization by a different clinician. The number of successful procedures of each type are reported.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PillCam COLON Standard Colonoscopy
Hide Arm/Group Description:
Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as "gold standard" comparison (with colon insufflation and sedation).
Overall Number of Participants Analyzed 328 328
Measure Type: Number
Unit of Measure: participants
322 326
2.Primary Outcome
Title Number of Participants With Indicated Lesions Detected by Standard Colonoscopy
Hide Description Since the standard colonoscopy is the "gold standard" to which the PillCam is to be compared, the number of participants with the indicated lesions identified by a trained clinician using standard colonoscopy procedures is reported here. Note that some Participants had multiple lesions and so could be included in more than one size category. Advanced adenoma is defined as 1) an adenoma 1 cm or larger or 2) an adenoma with villous features or high-grade dysplasia. All colorectal cancers were 6mm or larger.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Accuracy Analysis successfully had both capsule endoscopy and colonoscopy.
Arm/Group Title Standard Colonoscopy
Hide Arm/Group Description:
After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as "gold standard" comparison (with colon insufflation and sedation).
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: participants
Polyp, Any Size 212
Polyp, < 6 mm 188
Polyp, >= 6 mm 87
Polyp, >= 10 mm 50
Adenoma, >= 6 mm 71
Adenoma, >= 10 mm 45
Advanced Adenoma, Any Size 52
Advanced Adenoma, >= 6 mm 49
Advanced Adenoma, >= 10 mm 45
Colorectal Cancer 19
3.Primary Outcome
Title Sensitivity of Capsule Endoscopy for Indicated Lesions
Hide Description Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Sensitivity was calculated as the percentage of participants who had positive findings on capsule endoscopy (of a specified category) among those participants who had positive findings on colonoscopy of the same category (reported in Outcome Measure 1). The false negative rate is equal to 1 - sensitivity and indicated the percentage of lesions missed by capsule endoscopy.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.
Arm/Group Title PillCam COLON
Hide Arm/Group Description:
Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
Overall Number of Participants Analyzed 320
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Polyp, Any Size (n=212)
72
(68 to 75)
Polyp, < 6 mm (n=188)
61
(57 to 64)
Polyp, >= 6 mm (n=87)
64
(59 to 72)
Polyp, >= 10 mm (n=50)
60
(51 to 66)
Adenoma, >= 6 mm (n=71)
68
(58 to 76)
Adenoma, >= 10 mm (n=45)
64
(54 to 72)
Advanced Adenoma, Any Size (n=52)
85
(73 to 93)
Advanced Adenoma, >= 6 mm (n=49)
73
(61 to 83)
Advanced Adenoma, >= 10 mm (n=45)
64
(54 to 72)
Colorectal Cancer (n=19)
74
(52 to 88)
4.Primary Outcome
Title Specificity of Capsule Endoscopy for Indicated Lesions
Hide Description Readings of videos from the PillCam COLON were performed by trained physicians who identified lesions (types and sizes). Specificity was calculated as the percentage of participants who had negative findings on capsule endoscopy (of a specified category) among participants with negative colonoscopy findings of the same category (reported in Outcome Measure 1). This corresponds to 1 - the false positive rate.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Accuracy Analysis population had both successful capsule endoscopy and colonoscopy.
Arm/Group Title PillCam COLON
Hide Arm/Group Description:
Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
Overall Number of Participants Analyzed 320
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
Polyp, Any Size (n=108)
78
(71 to 84)
Polyp, < 6 mm (n=132)
82
(76 to 87)
Polyp, >= 6 mm (n=233)
84
(81 to 87)
Polyp, >= 10 mm (n=270)
98
(96 to 99)
Adenoma, >= 6 mm (n=249)
82
(79 to 84)
Adenoma, >= 10 mm (n=275)
97
(96 to 99)
Advanced Adenoma, Any Size (n=268)
50
(48 to 51)
Advanced Adenoma, >= 6 mm (n=271)
79
(77 to 81)
Advanced Adenoma, >= 10 mm (n=275)
97
(96 to 99)
Colorectal Cancer (n=301)
74
(72 to 75)
5.Secondary Outcome
Title Percent of Participants With Scoring Index 3 or 4
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PillCam COLON Standard Colonoscopy
Hide Arm/Group Description:
Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as "gold standard" comparison (with colon insufflation and sedation).
Overall Number of Participants Analyzed 320 320
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
72
(66 to 77)
87
(83 to 91)
6.Secondary Outcome
Title Number, Type and Severity of Adverse Events
Hide Description [Not Specified]
Time Frame Within 7 days
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy
Hide Description [Not Specified]
Time Frame within 7 days
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Excreted Colon Capsules
Hide Description [Not Specified]
Time Frame Within 7 days
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)
Hide Description [Not Specified]
Time Frame within 7 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Events Related to Colonoscopy Adverse Events Related to the Capsule
Hide Arm/Group Description AE related to colonoscopy procedure AE related to the capsule endoscopy procedure
All-Cause Mortality
Adverse Events Related to Colonoscopy Adverse Events Related to the Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Adverse Events Related to Colonoscopy Adverse Events Related to the Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/328 (0.00%)   0/328 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.52%
Adverse Events Related to Colonoscopy Adverse Events Related to the Capsule
Affected / at Risk (%) Affected / at Risk (%)
Total   0/328 (0.00%)   0/328 (0.00%) 
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: Hila Debby
Organization: Given Imaging
Phone: +972 4 9097774
EMail: Hila.Debby@givenimaging.com
Layout table for additonal information
Responsible Party: Hila Debby, Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00604162     History of Changes
Other Study ID Numbers: MA-53
First Submitted: January 24, 2008
First Posted: January 30, 2008
Results First Submitted: July 7, 2010
Results First Posted: February 18, 2011
Last Update Posted: August 1, 2019