Back to resultsPillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon (MA-53)
Primary Purpose
Colonic Diseases
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PillCam COLON
Standard colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonic Diseases focused on measuring Suspected colonic disease, Known colonic disease
Eligibility Criteria
Inclusion Criteria:
Subject was referred for colonoscopy for one of the following reasons:
- Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.
Any subject ≥ 18 years of age with:
- Positive findings in the colon on a GastroIntestinal (GI) radiographic study
- Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
- Suspected or known ulcerative colitis
Exclusion Criteria:
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
- Chronic use of laxatives
- Subject has a cardiac pacemakers or other implanted electro medical devices.
- Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Age < 18 years
- Subject suffers from life threatening conditions
- Subject is currently participating in another clinical study
- Subject has known slow gastric emptying time
Sites / Locations
- CHU Lyon
- CHU Nancy
- Evangelisches Krankenhaus
- AK Altona
- Ospedale Gemelli
- Clinica Universitaria de Navarra
- St.Marks&Northwick Park hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PillCam COLON and Colonoscopy
Arm Description
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases, had capsule endoscopy with PillCam COLON after bowel preparation and before standard colonoscopy.
Outcomes
Primary Outcome Measures
Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies
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.
Number of Participants With Indicated Lesions Detected by Standard Colonoscopy
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.
Sensitivity of Capsule Endoscopy for Indicated Lesions
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.
Specificity of Capsule Endoscopy for Indicated Lesions
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.
Secondary Outcome Measures
Percent of Participants With Scoring Index 3 or 4
Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:
poor cleansing level (Large amount of fecal residue.)
fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)
good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)
excellent cleansing level (No more than small bits of adherent feces.)
Number, Type and Severity of Adverse Events
Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy
Percentage of Excreted Colon Capsules
Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00604162
Brief Title
PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Acronym
MA-53
Official Title
Evaluation of PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
Detailed Description
The development and introduction of a specially designed, customized colon capsule combined with a dedicated capsule colonoscopy procedure protocol will allow for more efficient evaluation of the colonic mucosa. This is expected to improve the capability of the Given® Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening tool for colonic disease.
This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting colon abnormalities. Note that the physician performing the capsule endoscopy and reading the capsule videos and the physician performing the colonoscopy were unaware of each other's findings until completion of the examinations and reports (assessor-blind).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases
Keywords
Suspected colonic disease, Known colonic disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
332 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PillCam COLON and Colonoscopy
Arm Type
Experimental
Arm Description
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases, had capsule endoscopy with PillCam COLON after bowel preparation and before standard colonoscopy.
Intervention Type
Device
Intervention Name(s)
PillCam COLON
Intervention Description
The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.
Intervention Type
Procedure
Intervention Name(s)
Standard colonoscopy
Intervention Description
Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.
Primary Outcome Measure Information:
Title
Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies
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
Title
Number of Participants With Indicated Lesions Detected by Standard Colonoscopy
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
Title
Sensitivity of Capsule Endoscopy for Indicated Lesions
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
Title
Specificity of Capsule Endoscopy for Indicated Lesions
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
Secondary Outcome Measure Information:
Title
Percent of Participants With Scoring Index 3 or 4
Description
Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows:
poor cleansing level (Large amount of fecal residue.)
fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.)
good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.)
excellent cleansing level (No more than small bits of adherent feces.)
Time Frame
1 day
Title
Number, Type and Severity of Adverse Events
Time Frame
Within 7 days
Title
Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy
Time Frame
within 7 days
Title
Percentage of Excreted Colon Capsules
Time Frame
Within 7 days
Title
Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon)
Time Frame
within 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject was referred for colonoscopy for one of the following reasons:
Subjects over ≥ 50 years of age with one or more of the following clinical symptoms: rectal bleeding, hematochezia, melena, positive Fecal Occoult Blood Test (FOBT), recent change of bowel habits, or diarrhea/constipation of recent onset.
Any subject ≥ 18 years of age with:
Positive findings in the colon on a GastroIntestinal (GI) radiographic study
Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 3 years since last colonoscopy
Suspected or known ulcerative colitis
Exclusion Criteria:
Subject has dysphagia
Subject has congestive heart failure
Subject has renal insufficiency
Subject is known or is suspected to suffer from intestinal obstruction.
Chronic use of laxatives
Subject has a cardiac pacemakers or other implanted electro medical devices.
Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
Subject has any condition, which precludes compliance with study and/or device instructions.
Age < 18 years
Subject suffers from life threatening conditions
Subject is currently participating in another clinical study
Subject has known slow gastric emptying time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques DEVIERE, M.D
Organizational Affiliation
Hôpital Erasme
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Lyon
City
Lyon
Country
France
Facility Name
CHU Nancy
City
Nancy
Country
France
Facility Name
Evangelisches Krankenhaus
City
Dusseldorf
Country
Germany
Facility Name
AK Altona
City
Hamburg
Country
Germany
Facility Name
Ospedale Gemelli
City
Rome
Country
Italy
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
St.Marks&Northwick Park hospital
City
Harrow
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19605831
Citation
Van Gossum A, Munoz-Navas M, Fernandez-Urien I, Carretero C, Gay G, Delvaux M, Lapalus MG, Ponchon T, Neuhaus H, Philipper M, Costamagna G, Riccioni ME, Spada C, Petruzziello L, Fraser C, Postgate A, Fitzpatrick A, Hagenmuller F, Keuchel M, Schoofs N, Deviere J. Capsule endoscopy versus colonoscopy for the detection of polyps and cancer. N Engl J Med. 2009 Jul 16;361(3):264-70. doi: 10.1056/NEJMoa0806347. Erratum In: N Engl J Med. 2009 Sep 17;361(12):1220. Navas, Miguel Munoz [corrected to Munoz-Navas, Miguel].
Results Reference
result
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PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
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