Colonic IrrigationNCT02826967
Feasibility and Effectiveness of Colonic Irrigation
A study testing Colonic Irrigation in people with Colonic Irrigation, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will allow investigators to determine whether colonic irrigation may allow for a non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus increased cancer prevention and early… Read more about this study
- Who is it for?
- Ages 50 to 84 years
- Conditions the study is for
- Colonic Irrigation
- What is being tested?
- Colonic Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 8 Jun 2020
- 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 50 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients age 50-84 years old, who require a screening or surveillance colonoscopy
- Ability to give consent
Who cannot join
- Pregnancy
- History of ulcerative colitis or Crohn's disease
- History of surgical ostomy
- History of colorectal surgery
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: Feasibility and Effectiveness of Colonic Irrigation as a Non-oral, Same-day Bowel Preparation Option in Patients Undergoing Screening or Surveillance Colonoscopy
This study will allow investigators to determine whether colonic irrigation may allow for a non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus increased cancer prevention and early detection.
Read the detailed description
The primary endpoints for this study are:
- Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score) (6).
- Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.
- Conditions
- Colonic Irrigation
- Being tested
- Colonic Irrigation
- Keywords
- Hydro-San Plus colonic irrigation system, Screening colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonic IrrigationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Colonic Irrigation | Experimental | A designated health professional will administer to the patient the colonic irrigation procedure -using the Hydro-San Plus colon therapy system, an FDA approved and ISO certified device for colonic irrigation and cleansing before endoscopic procedures (FDA #2027347). Receives: Procedure: Colonic Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS)
Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score)
Measured: 15 Minutes
Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Why it stopped: COVID-19 institutional restrictions on screening colonoscopies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic IrrigationStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Pochapin, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826967
- Sponsor's protocol ID
- 16-00578
- Status last verified
- Jun 2020
- First submitted
- 6 Jul 2016
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Colonic Irrigation as a Non-oral, Same-day Bowel Preparation Option in Patients Undergoing Screening or Surveillance Colonoscopy
- ClinicalTrials.gov ID
- NCT02826967
- Acronym / sponsor ID
- 16-00578
- Conditions
- Colonic Irrigation
- Keywords
- Hydro-San Plus colonic irrigation system, Screening colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 institutional restrictions on screening colonoscopies
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 11 Jul 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.
This study will allow investigators to determine whether colonic irrigation may allow for a non-oral, same-day alternative to traditional oral bowel prep regimens. This in turn could lead to more persons able to undergo screening colonoscopy for colorectal cancer and thus increased cancer prevention and early detection.
Detailed description
The primary endpoints for this study are:
- Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score) (6).
- Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonic Irrigation | Experimental | Procedure: Colonic IrrigationA designated health professional will administer to the patient the colonic irrigation procedure -using the Hydro-San Plus colon therapy system, an FDA approved and ISO certified device for colonic irrigation and cleansing before endoscopic procedures (FDA #2027347). |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Outpatients age 50-84 years old, who require a screening or surveillance colonoscopy
- Ability to give consent
Key exclusion criteria (4 listed)
- Pregnancy
- History of ulcerative colitis or Crohn's disease
- History of surgical ostomy
- History of colorectal surgery
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 |
|---|---|---|
| Colonic Irrigation | Procedure or surgery | Colonic Irrigation |
Primary outcome
Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS)
Time frame: 15 Minutes
Boston Bowel Preparation Score (BBPS), a validated numerical scale for bowel cleanse (0-3 for each colon segment; 0-9 total score)
Patient satisfaction, as measured by a questionnaire administered by a study investigator via follow-up phone call after completion of the colonic irrigation and subsequent colonoscopy.
Time frame: 15 Minutes
Results and safety
The study was stopped early (reason given: COVID-19 institutional restrictions on screening colonoscopies). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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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.
Mark Pochapin, MD 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 Colonic Irrigation in people with Colonic Irrigation, 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 4 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: stopped early, as of the sponsor's last update on 1 Jul 2020. 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 stopped early (reason given: COVID-19 institutional restrictions on screening colonoscopies). Results are not available in the source record.
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?
Overall quality of bowel cleansing for each of the three segments of the colon (ascending, transverse, and descending) as measured by the Boston Bowel Preparation Score (BBPS) (time frame: 15 Minutes). The study lists 2 primary outcomes in all. 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 1 Jul 2020.