Evaluation of PillCam™ Colon 2 in Visualization of the Colon

Not Applicable

Completed

Conditions: Colonic Diseases
Bowel Diseases

Interventions: Device: PillCam™ (Capsule Endoscopy) Colon 2 capsule

Registration Number: NCT01087528

Lead Sponsor: Medtronic - MITG

Brief Summary: To evaluate the performance of PillCam COLON 2 in regards to detection of patients with polyps where colonoscopy is considered as the gold standard reference.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PillCam™ (Capsule Endoscopy) Colon 2 capsule	Subjects that are indicated for colonoscopy, who are suspected or known to suffer from large bowel diseases.

Primary Outcome Measures

Name	Time	Method
Accuracy of Detection in Patients With Colonic Polyps - Specificity	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.
Accuracy of Detection in Patients With Colonic Polyps - Sensitivity	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.

Secondary Outcome Measures

Name	Time	Method
Capsule Excretion Time	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
Diagnostic Yield of PillCam™ COLON 2 in Detecting Colonic Lesions	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)	within 7 days	Overall colon cleanliness was judged for capsule endoscopy and colonoscopy on a four-point grading index scale as follows: 1. poor cleansing level (Large amount of fecal residue.) 2. fair cleansing level (Enough feces or dark fluid present to preclude a completely reliable examination.) 3. good cleansing level (Small amount of feces or dark fluid, but not enough to interfere with examination.) 4. excellent cleansing level (No more than small bits of adherent feces.)

Trial Locations

Locations (4): Indiana University Medical Center
🇺🇸
Indianapolis, Indiana, United States
Digestive Care, Inc.
🇺🇸
Beavercreek, Ohio, United States
Gastroenterology Associates of Tidewater
🇺🇸
Chesapeake, Virginia, United States
University of North Carolina
🇺🇸
Chapel Hill, North Carolina, United States