Novel Irrigation Solution for Colonoscopy Visualization Pilot
ConditionColonoscopy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age45-75
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Olympus colonoscope
- Irrigation solution
Treatment groups
35 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov