drugset / Trial / NCT02893748
HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy
Withdrawn
HyGIeaCare, Inc.
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to compare the level of cleanliness using the HyGIeaCare Prep vs the standard of care Split-dose PEG prep used prior to colonoscopy.
Timeline
- Start
- 2019-03-01
- Primary completion
- 2019-03-01
- Completion
- 2019-03-01
Publications
- Background Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
- Background Gagneja HK, Parekh P, Burleson D, Johnson D. HyGIeaCare® Preparation for Colonoscopy - A Technical Update for Success. J Gastrointest Dig Syst 2016; 6: 458. doi:10.4172/2161-069X.1000458
- Background Clark BT, Protiva P, Nagar A, Imaeda A, Ciarleglio MM, Deng Y, Laine L. Quantification of Adequate Bowel Preparation for Screening or Surveillance Colonoscopy in Men. Gastroenterology. 2016 Feb;150(2):396-405; quiz e14-5. doi: 10.1053/j.gastro.2015.09.041. Epub 2015 Oct 9.
- Background Fiorito J, Culpepper-Morgan JA, Estabrook SG, Scofield P, Usatii V, Cuomo R. Hydrotherapy Compared with PEG-ES Lavage and Aqueous Sodium Phosphate as Bowel Preparation for Elective Colonoscopy: A Prospective, Randomized, Single Blinded Trial. ACG Abstract 2006; 751814.
- Background Sportes A, Delvaux M, Huppertz J, Hernandez C, Gay G. Randomized Trial Comparing High Volume Rectal Water Irrigation with Standard 4L Split-dose PEG Preparation Before Colonoscopy. Accepted by Gastroenterology and Digestive Diseases (awaiting publication).
- Background ASGE Standards of Practice Committee; Saltzman JR, Cash BD, Pasha SF, Early DS, Muthusamy VR, Khashab MA, Chathadi KV, Fanelli RD, Chandrasekhara V, Lightdale JR, Fonkalsrud L, Shergill AK, Hwang JH, Decker GA, Jue TL, Sharaf R, Fisher DA, Evans JA, Foley K, Shaukat A, Eloubeidi MA, Faulx AL, Wang A, Acosta RD. Bowel preparation before colonoscopy. Gastrointest Endosc. 2015 Apr;81(4):781-94. doi: 10.1016/j.gie.2014.09.048. Epub 2015 Jan 14. No abstract available.
- Background US Department of Health and Human Services. Common Terminology Criteria for Adverse Events 2009.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | polyethylene glycol | Other / unclassified | — | — |
Indications
No indication recorded.