Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: ProvidersExperimental treatment 2 interventions
Group B: PatientsExperimental treatment 2 interventions

Trial outcomes

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: