Novel Irrigation Solution for Colonoscopy Visualization Pilot

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07769905
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Colonoscopy

Eligibility Criteria

Sex
ALL
Age
45 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Olympus colonoscope — DEVICE
    The Olympus colonoscope will be used during the colonoscopy.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Providers
    Provider experience of use of the novel irrigation solution will be assessed.
  • Experimental: Patients
    Patients will receive the novel irrigation solution during their colonoscopies.

Primary Outcome Measure

Providers that observed increased mucosal visibility [ Time Frame: End of procedure (Day 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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