This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients. Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.
This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE. Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
122
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Indianapolis Gastroenterology and Hepatology
Indianapolis, Indiana, United States
Dayton Gastroenterology
Dayton, Ohio, United States
Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)
The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).
Time frame: Within two weeks of study procedure
Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE
Will be assessed from RAPID video in total and by segment
Time frame: an expected average of 3 weeks from study procedure
Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE
Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment
Time frame: an expected average of 3 weeks from study procedure
Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE
Will be assessed from RAPID video in total and by segment
Time frame: an expected average of 3 weeks from study procedure
Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE
Will be assesses by applicable case report form (CRF)
Time frame: an expected average of 3 weeks from study procedure
Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE
Will be assesses by applicable CRF
Time frame: Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.
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Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Franklin Gastroenterology, PLLC
Franklin, Tennessee, United States