Novel Irrigation Solution for Colonoscopy Visualization Pilot
A Pilot Evaluation of a Novel Irrigation Solution to Enhance Visualization During Colonoscopy
1 other identifier
interventional
35
1 country
1
Brief 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. Specifically, the study will assess mucosal visibility, colonic spasm, and intralumenal bubbles observed during colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2026
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2026
CompletedFirst Posted
Study publicly available on registry
August 18, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
August 18, 2026
August 1, 2026
3 months
August 13, 2026
August 13, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Providers that observed increased mucosal visibility
End of procedure (Day 1)
Providers who observed a reduction colonic spasm
End of procedure (Day 1)
Providers that observed decreased intraluminal bubbles during colonoscopy
End of procedure (Day 1)
Study Arms (2)
Providers
EXPERIMENTALProvider experience of use of the novel irrigation solution will be assessed.
Patients
EXPERIMENTALPatients will receive the novel irrigation solution during their colonoscopies.
Interventions
The Olympus colonoscope will be used during the colonoscopy.
Sterile water mixed with peppermint oil, tween, indigo carmine, and simethicone. A maximum of 1 liter of solution will be provided per procedure.
Eligibility Criteria
You may qualify if:
- 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
- Faculty gastroenterologist at NYU Langone Ambulatory Care Center
- At least 18 years of age
- Willingness to provide consent
You may not qualify if:
- 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
- \. Not a gastroenterology provider at NYULH
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Pochapin, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2026
First Posted
August 18, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
August 18, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Mark.Pochapin@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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.