Colonoscopy
Conditions
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.
Interventions
DEVICEOlympus colonoscope
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.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| 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) |
Countries
United States
Contacts
CONTACTMark Pochapin, MD
CONTACTAbraham Cheloff, MD, MS
PRINCIPAL_INVESTIGATORMark Pochapin, MD
NYU Langone Health
Outcome results
None listed