HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

Colonoscopy Clinical Trial

Official title:

HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02893748
• Other study ID #: HGP-0004
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2018
• Source: HyGIeaCare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The level of cleanliness will be recorded using the Boston Bowel Prep Score (BBPS) by an endoscopist who is blind to the randomized preparation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patient referred to colonoscopy

2. Patient with high probability for poor prep due to one or more of the following:

1. Chronic constipation (Rome III functional constipation criteria)

2. Gastroparesis

3. Immobilization

4. Diabetes

5. History of poor prep

Exclusion Criteria:

1. 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.

2. Patient is currently taking narcotics.

3. Patient has any of the contraindications listed below:

1. Cardiac: Congestive heart failure (NYHA class III or IV or EF < 50%)

2. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery

3. GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites

4. Abdominal surgery within the last 6 months

5. Pregnancy

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Device:
• HyGIeaCare Prep
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.

Procedure:
• Colonoscopy
Screening colonoscopy as per standard of care.

Drug:
• polyethylene glycol (PEG)
PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HyGIeaCare, Inc.

References & Publications (7)

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. — View Citation

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. — View Citation

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.

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

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. Review. — View Citation

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).

US Department of Health and Human Services. Common Terminology Criteria for Adverse Events 2009.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)		Day 1 of colonoscopy
Secondary	Evaluation of patient satisfaction using a Questionnaire	Questionnaire	2 Days after colonoscopy
Secondary	Evaluation of adverse events	Questionnaire	2 Days after colonoscopy