Novel Irrigation Solution for Colonoscopy Visualization Pilot

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colonoscopy
• Intervention / Treatment: Device: Olympus colonoscope; Drug: Irrigation solution

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mark Pochapin, MD; Phone Number: 212-263-3096; Email: Mark.pochapin@nyulangone.org
• Study Contact Backup: Name: Abraham Cheloff, MD, MS; Email: Abraham.cheloff@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

1. Between 45 to 75 years of age
2. Currently receiving gastroenterology or primary care at NYU Langone Hospital
3. Capacity and willingness to provide consent
4. Undergoing a screening colonoscopy

Provider Inclusion Criteria:

1. Faculty gastroenterologist at NYU Langone Ambulatory Care Center
2. At least 18 years of age
3. Willingness to provide consent

Patient Exclusion Criteria:

1. Under 45 years or over 75 years of age
2. Known allergy to blue dye, peppermint and/or simethicone
3. Current use of antispasmodics or anti-flatulance agents
4. 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:

1. Not a gastroenterology provider at NYULH

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Providers; Provider experience of use of the novel irrigation solution will be assessed.	Device: Olympus colonoscope; The Olympus colonoscope will be used during the colonoscopy.; Other Names: CF EZ1500DL; CF HQ190; PCF H190DL/I/TI/TL; Drug: Irrigation solution; Sterile water mixed with peppermint oil, tween, indigo carmine, and simethicone. A maximum of 1 liter of solution will be provided per procedure.
Experimental: Patients; Patients will receive the novel irrigation solution during their colonoscopies.	Device: Olympus colonoscope; The Olympus colonoscope will be used during the colonoscopy.; Other Names: CF EZ1500DL; CF HQ190; PCF H190DL/I/TI/TL; Drug: Irrigation solution; Sterile water mixed with peppermint oil, tween, indigo carmine, and simethicone. A maximum of 1 liter of solution will be provided per procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mark Pochapin, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: August 13, 2026
• First Submitted That Met QC Criteria: August 13, 2026
• First Posted (Actual): August 18, 2026

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 25-01044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No