ColonoscopyNCT02893748
HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy
A study testing HyGIeaCare Prep, Colonoscopy and polyethylene glycol (PEG) in people with Colonoscopy, run by HyGIeaCare, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- HyGIeaCare Prep, Colonoscopy and polyethylene glycol (PEG)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Conditions
- Colonoscopy
- Being tested
- HyGIeaCare Prep, Colonoscopy, polyethylene glycol (PEG)
- Keywords
- colon, polyps, cancer, screening
- Medical subject headings
- Polyps, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyGIeaCare PrepDevice
Also called colon lavage
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.
ColonoscopyProcedure or surgery
Also called Screening Colonoscopy
Screening colonoscopy as per standard of care.
polyethylene glycol (PEG)Drug
Also called Split-dose PEG Prep
PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1: HyGIeaCare Prep and Colonoscopy | Active comparator | Patients will receive:
1. HyGIeaCare Prep
2. Colonoscopy Receives: Device: HyGIeaCare Prep; Procedure: Colonoscopy |
| 2: Split-dose PEG Prep and Colonoscopy | Active comparator | Patients will receive:
1. Split-dose PEG
2. Colonoscopy Receives: Procedure: Colonoscopy; Drug: polyethylene glycol (PEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)
Measured: Day 1 of colonoscopy
Secondary outcomes (2)
Evaluation of patient satisfaction using a Questionnaire
Questionnaire
Measured: 2 Days after colonoscopy
Evaluation of adverse events
Questionnaire
Measured: 2 Days after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start1 Mar 2019
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Why it stopped: unable to agree on budget terms
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HyGIeaCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Umar, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893748
- Sponsor's protocol ID
- HGP-0004
- Status last verified
- Feb 2018
- First submitted
- 24 Aug 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 25239068Gagneja 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 26439436Fiorito 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 25595062US Department of Health and Human Services. Common Terminology Criteria for Adverse Events 2009.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HyGIeaCare Prep vs Split-dose PEG Prep Prior to Colonoscopy
- ClinicalTrials.gov ID
- NCT02893748
- Acronym / sponsor ID
- HGP-0004
- Conditions
- Colonoscopy
- Keywords
- colon, polyps, cancer, screening
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to agree on budget terms
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HyGIeaCare, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: HyGIeaCare Prep and Colonoscopy | Active comparator | Device: HyGIeaCare Prep, Procedure: ColonoscopyPatients will receive: 1. HyGIeaCare Prep 2. Colonoscopy |
| 2: Split-dose PEG Prep and Colonoscopy | Active comparator | Procedure: Colonoscopy, Drug: polyethylene glycol (PEG)Patients will receive: 1. Split-dose PEG 2. Colonoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient referred to colonoscopy
- Patient with high probability for poor prep due to one or more of the following:
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyGIeaCare PrepAlso: colon lavagePatients 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. | Device | 1: HyGIeaCare Prep and Colonoscopy |
| ColonoscopyAlso: Screening ColonoscopyScreening colonoscopy as per standard of care. | Procedure or surgery | 1: HyGIeaCare Prep and Colonoscopy, 2: Split-dose PEG Prep and Colonoscopy |
| polyethylene glycol (PEG)Also: Split-dose PEG PrepPEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy | Drug | 2: Split-dose PEG Prep and Colonoscopy |
Primary outcome
Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS)
Time frame: Day 1 of colonoscopy
2 secondary outcomes
Evaluation of patient satisfaction using a Questionnaire
Time frame: 2 Days after colonoscopy
Evaluation of adverse events
Time frame: 2 Days after colonoscopy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Background: PubMed 25239068Johnson 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.
- BackgroundGagneja 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: PubMed 26439436Clark 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.
- BackgroundFiorito 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).
- Background: PubMed 25595062ASGE 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.
- BackgroundUS Department of Health and Human Services. Common Terminology Criteria for Adverse Events 2009.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Umar, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing HyGIeaCare Prep, Colonoscopy and polyethylene glycol (PEG) in people with Colonoscopy, run by HyGIeaCare, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colon cleanliness will be measured in both groups according to the Boston Bowel Preparation Scale (BBPS) (time frame: Day 1 of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893748, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.