Phase 3
N=332
PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Colonic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00604162 ↗Enrolled (actual)
332
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies — 322; 326 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PillCam COLON (Device); Standard colonoscopy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies |
322; 326 | — |
| PRIMARY Number of Participants With Indicated Lesions Detected by Standard Colonoscopy |
212; 188; 87; 50; 71; 45 | — |
| PRIMARY Sensitivity of Capsule Endoscopy for Indicated Lesions |
72; 61; 64; 60; 68; 64 | — |
| PRIMARY Specificity of Capsule Endoscopy for Indicated Lesions |
78; 82; 84; 98; 82; 97 | — |
| SECONDARY Percent of Participants With Scoring Index 3 or 4 |
72; 87 | — |
| SECONDARY Number, Type and Severity of Adverse Events |
— | — |
| SECONDARY Accuracy Parameters (Sensitivity, Specificity, Negative Predicted Value, Positive Predicted Value) of Colon Capsule Endoscopy, Compared to Standard Colonoscopy |
— | — |
| SECONDARY Percentage of Excreted Colon Capsules |
— | — |
| SECONDARY Colon Capsule Endoscopy Transit Time Per Section (Stomach, Small Bowel, Colon) |
— | — |
Summary
To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
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
Data sourced from ClinicalTrials.gov (NCT00604162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.