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NCT Number: NCT07769905

Novel Irrigation Solution for Colonoscopy Visualization Pilot

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.

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Key information

Conditions

Colonoscopy

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olympus colonoscope

Device

The Olympus colonoscope will be used during the colonoscopy.

Other names: CF EZ1500DL, CF HQ190, PCF H190DL/I/TI/TL

Irrigation solution

Drug

Sterile water mixed with peppermint oil, tween, indigo carmine, and simethicone. A maximum of 1 liter of solution will be provided per procedure.

Primary outcomes

  1. Providers that observed increased mucosal visibility

    Time frame: End of procedure (Day 1)

  2. Providers who observed a reduction colonic spasm

    Time frame: End of procedure (Day 1)

  3. Providers that observed decreased intraluminal bubbles during colonoscopy

    Time frame: End of procedure (Day 1)

Study contacts

Contact information is provided by the study sponsor or research team.

Abraham Cheloff, MD, MS

CONTACT

[email protected]

Mark Pochapin, MD

CONTACT

[email protected]

212-263-3096

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Pilot Evaluation of a Novel Irrigation Solution to Enhance Visualization During Colonoscopy

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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