Evaluation of PillCam™ Colon 2 in Visualization of the Colon
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|ClinicalTrials.gov Identifier: NCT01087528|
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : June 8, 2012
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colonic Diseases Bowel Diseases||Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule||Not Applicable|
Standard evaluation of subjects with suspected colon diseases includes endoscopic imaging by colonoscopy and radiology testing such as: air-contrast barium enema, abdominal/pelvic CT, or virtual colonoscopy.
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . Furthermore, compared to standard colonoscopy, the Given® Diagnostic System may be more readily accepted by the subjects, thereby improving subjects' willingness to undergo a diagnostic evaluation of the colon and comply with colorectal cancer screening recommendations.
The PillCam™ SB capsule (formerly M2A® Capsule) that was cleared by the FDA- in August 2001 for small bowel evaluation has been ingested to date by more than 1,000,000 people worldwide and is well accepted by patients and physicians as well as the professional societies. However, adequate visualization of the colon cannot be achieved with the standard PillCam™ SB capsule because of the anatomical and physiological properties of the colon which are significantly different than the small bowel. Moreover, other issues that limit the evaluation of the colonic mucosa by the standard PillCam™ SB procedure include an unsatisfactory level of colon cleanliness and slow progression of the PillCam™ SB capsule through the colon during the desired examination time. Therefore, 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. To date, several clinical studies have been conducted with Given® Diagnostic System and the PillCam™ Colon 1 capsule A pilot multicenter study is currently being conducted with a new Given® Diagnostic System and an advanced generation of the the PillCam™ Colon capsule - PillCam™ Colon 2. Capsule. The new development of Given® Diagnostic System and PillCam™ Colon 2 capsule is primarily aimed to increase sensitivity and specificity for polyp detection.
Further details of the Given® Diagnostic System and PillCam™ Colon 2 capsule can be found in the device description section.
This study is designed to evaluate the performance of the new version of Given® Diagnostic System and PillCam™ Colon 2 capsule in detecting patients with polyps and other colonic lesions as compared to conventional colonoscopy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of PillCam™ Colon 2 in Visualization of the Colon|
|Actual Study Start Date :||July 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.
Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule
- Accuracy of Detection in Patients With Colonic Polyps - Sensitivity [ Time Frame: within 7 days ]The accuracy parameters (i.e. sensitivity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.
- Accuracy of Detection in Patients With Colonic Polyps - Specificity [ Time Frame: within 7 days ]The accuracy parameters (i.e. specificity) were evaluated for detection of patients with polyps equal or larger than 6 mm and for detection of patients with polyps equal or larger than 10 mm by constructing 2X2 matrix (i.e. PCCE-2 performance versus the standard colonoscopy), where sensitivity and specificity, are presented with 95% Cl based on the binomial distribution. Standard colonoscopy is considered the gold standard.
- Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions [ Time Frame: within 7 days ]The diagnostic yield (%) of PCCE-2 and colonoscopy in visualizing a variety of colonic lesion excluding polyps (e.g. inflammation, diverticulosis and bleeding lesions) is provided.
- Percent of Participants With Scoring Index 3 or 4 (Good or Excellent) [ Time Frame: within 7 days ]
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.)
- Capsule Excretion Time [ Time Frame: within 7 days ]
Capsule excretion time is defined as the duration of ingestion to capsule excretion time. The distribution of excretion times were categorized as follows:
- capsule excreted within 4 hours
- capsule excreted within 6 hours
- capsule excreted within 8 hours
- capsule excreted 8 hours and above
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087528
|United States, Indiana|
|Indiana University Medical Center|
|Indianapolis, Indiana, United States, 46202|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Ohio|
|Digestive Care, Inc.|
|Beavercreek, Ohio, United States, 45440|
|United States, Virginia|
|Gastroenterology Associates of Tidewater|
|Chesapeake, Virginia, United States, 23320|
|Principal Investigator:||Douglas Rex, Dr.||Division of Gastroenterology, Indiana University Medical Center|