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WithdrawnNCT02893748Updated Sep 23, 2019

HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy

An interventional study of HyGIeaCare Prep and Colonoscopy in Colonoscopy, sponsored by HyGIeaCare, Inc.. Withdrawn. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-23.

Sponsored by HyGIeaCare, Inc. · Not applicable, Interventional, and Treatment

Why this study was withdrawn
unable to agree on budget terms
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Colonoscopy

Keywords

  • colon
  • polyps
  • cancer
  • screening
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In context

Lead sponsor

HyGIeaCare, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    1: HyGIeaCare Prep and Colonoscopy

    Patients will receive: 1. HyGIeaCare Prep 2. Colonoscopy

    Device: HyGIeaCare Prep · Procedure: Colonoscopy

  • Active comparator
    2: Split-dose PEG Prep and Colonoscopy

    Patients will receive: 1. Split-dose PEG 2. Colonoscopy

    Procedure: Colonoscopy · Drug: polyethylene glycol (PEG)

Interventions

  • DeviceHyGIeaCare 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.

    Also known as: colon lavage

  • ProcedureColonoscopy

    Screening colonoscopy as per standard of care.

    Also known as: Screening Colonoscopy

  • Drugpolyethylene glycol (PEG)

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

    Also known as: Split-dose PEG Prep

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What researchers measure

Primary outcomes

  1. Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)

    Time frame: Day 1 of colonoscopy

Secondary outcomes

  1. Evaluation of patient satisfaction using a Questionnaire

    Questionnaire

    Time frame: 2 Days after colonoscopy

  2. Evaluation of adverse events

    Questionnaire

    Time frame: 2 Days after colonoscopy

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 25239068 ↗
  • 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
  • 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. PubMed 26439436 ↗
  • 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.
  • 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).
  • 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. PubMed 25595062 ↗
  • US Department of Health and Human Services. Common Terminology Criteria for Adverse Events 2009.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02893748
Lead sponsor
HyGIeaCare, Inc.
Responsible party
Sponsor
First posted
Sep 8, 2016
Start date
Mar 1, 2019
Primary completion
Mar 1, 2019
Completion
Mar 1, 2019
Last update
Sep 23, 2019

Study contacts

Sarah Umar, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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