HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

NCT ID: NCT02893748

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-03-01

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.

Detailed 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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1: HyGIeaCare Prep and Colonoscopy

Patients will receive:

1. HyGIeaCare Prep

2. Colonoscopy

Group Type: ACTIVE_COMPARATOR

HyGIeaCare Prep

Intervention Type: DEVICE

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.

Colonoscopy

Intervention Type: PROCEDURE

Screening colonoscopy as per standard of care.

2: Split-dose PEG Prep and Colonoscopy

Patients will receive:

1. Split-dose PEG

2. Colonoscopy

Group Type: ACTIVE_COMPARATOR

Colonoscopy

Intervention Type: PROCEDURE

Screening colonoscopy as per standard of care.

polyethylene glycol (PEG)

Intervention Type: DRUG

PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy

Interventions

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.

Intervention Type: DEVICE

Colonoscopy

Screening colonoscopy as per standard of care.

Intervention Type: PROCEDURE

polyethylene glycol (PEG)

PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy

Intervention Type: DRUG

Other Intervention Names

colon lavage; Screening Colonoscopy; Split-dose PEG Prep

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HyGIeaCare, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Umar, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

References

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.

Reference Type: BACKGROUND

PMID: 25239068 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 26439436 (View on PubMed)

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.

Reference Type: 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).

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 25595062 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

HGP-0004

Identifier Type: -

Identifier Source: org_study_id