Study Stopped
unable to agree on budget terms
HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedSeptember 23, 2019
February 1, 2018
Same day
August 24, 2016
September 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)
Day 1 of colonoscopy
Secondary Outcomes (2)
Evaluation of patient satisfaction using a Questionnaire
2 Days after colonoscopy
Evaluation of adverse events
2 Days after colonoscopy
Study Arms (2)
1: HyGIeaCare Prep and Colonoscopy
ACTIVE COMPARATORPatients will receive: 1. HyGIeaCare Prep 2. Colonoscopy
2: Split-dose PEG Prep and Colonoscopy
ACTIVE COMPARATORPatients will receive: 1. Split-dose PEG 2. Colonoscopy
Interventions
Patients will receive the HyGIeaCare Prep, which is an open colon lavage system using warm water by gravity drip to evacuate the colon by stimulating peristalsis to cleanse the colon prior to colonoscopy.
Screening colonoscopy as per standard of care.
PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy
Eligibility Criteria
You may qualify if:
- Patient referred to colonoscopy
- Patient with high probability for poor prep due to one or more of the following:
- Chronic constipation (Rome III functional constipation criteria)
- Gastroparesis
- Immobilization
- Diabetes
- History of poor prep
You may not qualify if:
- Patient has any condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study.
- Patient is currently taking narcotics.
- Patient has any of the contraindications listed below:
- Cardiac: Congestive heart failure (NYHA class III or IV or EF \< 50%)
- GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
- GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
- Abdominal surgery within the last 6 months
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HyGIeaCare, Inc.lead
Related Publications (7)
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.
PMID: 25239068BACKGROUNDGagneja 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
BACKGROUNDClark 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.
PMID: 26439436BACKGROUNDFiorito 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.
BACKGROUNDSportes 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).
BACKGROUNDASGE 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.
PMID: 25595062BACKGROUNDUS Department of Health and Human Services. Common Terminology Criteria for Adverse Events 2009.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Umar, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2016
First Posted
September 8, 2016
Study Start
March 1, 2019
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
September 23, 2019
Record last verified: 2018-02