ColonoscopyPhase 1NCT07769905
Novel Irrigation Solution for Colonoscopy Visualization Pilot
A Phase 1 study testing Olympus colonoscope and Irrigation solution in people with Colonoscopy, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to assess the provider experience with a novel colonoscopy irrigation solution and determine the feasibility of introducing this solution into the endoscopy unit and assess efficacy on a small scale prior to a larger study. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Olympus colonoscope and Irrigation solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2027
- Phase
- Phase 1
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion Criteria:
- Between 45 to 75 years of age
- Currently receiving gastroenterology or primary care at NYU Langone Hospital
- Capacity and willingness to provide consent
- Undergoing a screening colonoscopy
Provider Inclusion Criteria:
- Faculty gastroenterologist at NYU Langone Ambulatory Care Center
- At least 18 years of age
- Willingness to provide consent
Patient Exclusion Criteria:
- Under 45 years or over 75 years of age
- Known allergy to blue dye, peppermint and/or simethicone
- Current use of antispasmodics or anti-flatulance agents
- Pregnancy: This exclusion is based on standard clinical practice and safety considerations, as colonoscopy is not typically performed during pregnancy except in urgent circumstances. Accordingly, inclusion of pregnant individuals in this elective, pilot feasibility study would not be clinically appropriate or scientifically justified.
Provider Exclusion Criteria:
- Not a gastroenterology provider at NYULH
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abraham Cheloff, MD, MS contact
About this study
Official title: A Pilot Evaluation of a Novel Irrigation Solution to Enhance Visualization During Colonoscopy
The purpose of this study is to assess the provider experience with a novel colonoscopy irrigation solution and determine the feasibility of introducing this solution into the endoscopy unit and assess efficacy on a small scale prior to a larger study. Specifically, the study will assess mucosal visibility, colonic spasm, and intralumenal bubbles observed during colonoscopy.
- Conditions
- Colonoscopy
- Being tested
- Olympus colonoscope, Irrigation solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olympus colonoscopeDevice
Also called CF EZ1500DL, CF HQ190, PCF H190DL/I/TI/TL
The Olympus colonoscope will be used during the colonoscopy.
Irrigation solutionDrug
Sterile water mixed with peppermint oil, tween, indigo carmine, and simethicone. A maximum of 1 liter of solution will be provided per procedure.
| Study group | Role | What they receive |
|---|---|---|
| Providers | Experimental | Provider experience of use of the novel irrigation solution will be assessed. Receives: Device: Olympus colonoscope; Drug: Irrigation solution |
| Patients | Experimental | Patients will receive the novel irrigation solution during their colonoscopies. Receives: Device: Olympus colonoscope; Drug: Irrigation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Providers that observed increased mucosal visibility
Measured: End of procedure (Day 1)
Providers who observed a reduction colonic spasm
Measured: End of procedure (Day 1)
Providers that observed decreased intraluminal bubbles during colonoscopy
Measured: End of procedure (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (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 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Pochapin, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769905
- Sponsor's protocol ID
- 25-01044
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Mark.Pochapin@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.