ColonoscopyNCT02647229
Colonic Irrigation for Colonoscopy Preparation
A study testing Isosmotic bowel cleansing preparation and Colonic Hyrdrotherapy in people with Colonoscopy, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Isosmotic bowel cleansing preparation and Colonic Hyrdrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adult patients (>18 years old) who require screening or surveillance colonoscopy
- Ability to give consent
Who cannot join
- Inability to obtain informed consent
- Pregnant patients
- Patients under the age of 18
- Active ulcerative colitis or crohn's disease flare
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy
The purpose of this physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. Patients will be randomized to receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic irrigation and cleansing before endoscopic procedures.
- Conditions
- Colonoscopy
- Being tested
- Isosmotic bowel cleansing preparation, Colonic Hyrdrotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosmotic bowel cleansing preparationOther
Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.
Colonic HyrdrotherapyOther
Also called Hydro San Plus Colon therapy system
FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician
| Study group | Role | What they receive |
|---|---|---|
| Isosmotic bowel cleansing preparation | Active comparator | Isosmotic solution ingested prior to colonoscopy Receives: Other: Isosmotic bowel cleansing preparation |
| Colonic Hyrdrotherapy | Active comparator | Colonic hydrotherapy is an FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician.2 There Receives: Other: Colonic Hyrdrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Boston Bowel Prep Score (BBPS)
Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)
Measured: 1 Day
Secondary outcomes (4)
Difference in Adenoma Detection Rate (ADR)
Measured: 1 Day
Difference in the number of follow ups needed after colonoscopy
Measured: 1 Day
Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
Measured: 1 Day
preferences regarding type of bowel prep for future colonoscopy based on difference in score between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Basil Lucak, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647229
- Sponsor's protocol ID
- 14-01351
- Status last verified
- Sep 2016
- First submitted
- 22 Dec 2015
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Effectiveness and Utility of Colonic Irrigation for Bowel Preparation in Patients Undergoing Screening or Surveillance Colonoscopy
- ClinicalTrials.gov ID
- NCT02647229
- Acronym / sponsor ID
- 14-01351
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 6 Jan 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 physician blinded, randomized study is to determine the utility, effectiveness, and feasibility of using colonic irrigation as a substitute for standard oral colonic purgative solutions for colonoscopy preparation. Patients will be randomized to receive either oral isosmotic solution (PEG) or colonic irrigation using the Hydro San Plus Colon therapy system, an FDA approved and isosmotic (ISO) certified device for colonic irrigation and cleansing before endoscopic procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isosmotic bowel cleansing preparation | Active comparator | Other: Isosmotic bowel cleansing preparationIsosmotic solution ingested prior to colonoscopy |
| Colonic Hyrdrotherapy | Active comparator | Other: Colonic HyrdrotherapyColonic hydrotherapy is an FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician.2 There |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive adult patients (>18 years old) who require screening or surveillance colonoscopy
- Ability to give consent
Key exclusion criteria (5 listed)
- Inability to obtain informed consent
- Pregnant patients
- Patients under the age of 18
- Active ulcerative colitis or crohn's disease flare
- Prisoners
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 |
|---|---|---|
| Isosmotic bowel cleansing preparationIsosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions. | Other | Isosmotic bowel cleansing preparation |
| Colonic HyrdrotherapyAlso: Hydro San Plus Colon therapy systemFDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician | Other | Colonic Hyrdrotherapy |
Primary outcome
Comparison of Boston Bowel Prep Score (BBPS)
Time frame: 1 Day
Quality of bowel preparations validated by numerical scale for bowel cleanse (0-9 best)
4 secondary outcomes
Difference in Adenoma Detection Rate (ADR)
Time frame: 1 Day
Difference in the number of follow ups needed after colonoscopy
Time frame: 1 Day
Difference in overall comfort and convenience between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
Time frame: 1 Day
preferences regarding type of bowel prep for future colonoscopy based on difference in score between Colonic Hydrotherapy and Isosmotic Irrigation using Boston Bowel Preparation Score (BBPS)
Time frame: 1 Day
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 28 Sep 2016.
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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.
Basil Lucak principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isosmotic bowel cleansing preparation and Colonic Hyrdrotherapy in people with Colonoscopy, run by NYU Langone Health at 1 site in United States.
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 2 inclusion and 5 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Comparison of Boston Bowel Prep Score (BBPS) (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2016.