NCT03458390

Use of a Colon Irrigation Device as a Preparation for a Colon Visualization Procedure

Colon Irrigation Using HyGIeaCare as Prep for PillCam COLON Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: HyGIeaCare, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Screening Colonoscopy

Interventions

Type	Name	Description
DEVICE	HyGIeaCare colon irrigation	PillCam COLON for visualization of bowel lining

Timeline

• Start date: 2019-06-27
• Primary completion: 2020-01-19
• Completion: 2020-01-19
• First posted: 2018-03-08
• Last updated: 2020-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study