A prospective, single center, study to evaluate the effectiveness of the HyGIeaCare Prep when used in combination with the PillCam COLON; the hypothesis is that the HyGIeaCare Prep will be easier for the patients to tolerate, and the results will be as good as the existing oral preparation.
Patients who agree to participate in the study will have their HyGIeaCare procedure and then will present to the PillCam COLON room, in the same suite for the PillCam COLON procedure. The commercial preparations for the PillCam COLON procedure will be the same, except the HyGIeaCare procedure will replace the split polyethylene glycol-electrolyte solution preparation. 2-days prior: * Normal diet * 10 glasses of liquid 1-day prior: * Clear liquid diet all day * Dulcolax 2 tabs at 2pm and 2 tabs at 8pm * Nothing by mouth after midnight Day of Procedure: * 6am- Dulcolax 2 tabs * 8am- HyGIeaCare Procedure * 9am- ingest PillCam Colon * 10am- ingest Reglan * At small bowel detection, drink 10oz SUPREP and 32oz water * 3hrs later- drink 10oz SUPREP and 32oz water * 2hrs later- insert suppository * 2hrs later- light meal
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
10
PillCam COLON for visualization of bowel lining
HyGIeaCare Center
Austin, Texas, United States
Effectiveness of colon irrigation
Effectiveness of the HyGIeaCare Prep will be measured using a 5-point scale to evaluate the visual quality of bowel cleanliness identified in the PillCam Colon video (Excellent, Good, Fair, Adequate, Poor).
Time frame: Immediately after colon irrigation, PillCam COLON will be administered. A video will be taken of the procedure which will be used to measure the effectiveness of the colon irrigation.
Evaluation of adverse events
The CTCAE tool will be used to evaluate outcomes
Time frame: To be evaluated the day of the procedure
Evaluation of patient satisfaction
A standardized questionnaire will be used to measure outcomes
Time frame: To be evaluated on the day of the procedure
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