Novel Irrigation Solution for Colonoscopy Visualization Pilot
13. august 2026 opdateret af: NYU Langone Health
A Pilot Evaluation of a Novel Irrigation Solution to Enhance Visualization During Colonoscopy
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
35
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mark Pochapin, MD
- Telefonnummer: 212-263-3096
- E-mail: Mark.pochapin@nyulangone.org
Undersøgelse Kontakt Backup
- Navn: Abraham Cheloff, MD, MS
- E-mail: Abraham.cheloff@nyulangone.org
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10016
- NYU Langone Health
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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:
1. Not a gastroenterology provider at NYULH
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Providers
Provider experience of use of the novel irrigation solution will be assessed.
|
The Olympus colonoscope will be used during the colonoscopy.
Andre navne:
Sterile water mixed with peppermint oil, tween, indigo carmine, and simethicone.
A maximum of 1 liter of solution will be provided per procedure.
|
|
Eksperimentel: Patients
Patients will receive the novel irrigation solution during their colonoscopies.
|
The Olympus colonoscope will be used during the colonoscopy.
Andre navne:
Sterile water mixed with peppermint oil, tween, indigo carmine, and simethicone.
A maximum of 1 liter of solution will be provided per procedure.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Providers that observed increased mucosal visibility
Tidsramme: End of procedure (Day 1)
|
End of procedure (Day 1)
|
|
Providers who observed a reduction colonic spasm
Tidsramme: End of procedure (Day 1)
|
End of procedure (Day 1)
|
|
Providers that observed decreased intraluminal bubbles during colonoscopy
Tidsramme: End of procedure (Day 1)
|
End of procedure (Day 1)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Mark Pochapin, MD, NYU Langone Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. december 2026
Studieafslutning (Anslået)
1. marts 2027
Datoer for studieregistrering
Først indsendt
13. august 2026
Først indsendt, der opfyldte QC-kriterier
13. august 2026
Først opslået (Faktiske)
18. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 25-01044
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health.
This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB).
Requests should be directed to: Mark.Pochapin@nyulangone.org.
The protocol and statistical analysis plan will be posted on Clinicaltrials.gov
only as required by federal regulation or supporting awards and agreements.
IPD-delingstidsramme
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD-delingsadgangskriterier
The investigator who proposed to use the data will be granted access upon reasonable request.
Requests should be directed to Mark.Pochapin@nyulangone.org.
To gain access, data requestors will need to sign a data access agreement.
This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .