- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07661914
AI_Colonoscopy_for_Fellows
Efficacy of Artificial Intelligence Assisted Colonoscopy in Improving Adenoma Detection Rates for Gastroenterology Fellows
The goal of this study is to look at how good artificial intelligence (AI) assisted colonoscopy is compared to conventional colonoscopy in detecting polyps when used by gastroenterology fellows. The main question the study aims to answer are:
Does AI assisted colonoscopy improve adenoma detection rate for gastroenterology fellows in different levels of training? Does AI assisted colonoscopy improve other quality indicators such as sessile serrated lesion detection rate withdrawal time? This research will compare these quality measures for gastroenterology fellows in their first, second, and third year of training. The gastroenterology fellows performing colonoscopies will be randomized to either AI assisted colonoscopy or conventional colonoscopy for each case. The nurse in the room will then turn on the AI device if needed and the rest of the colonoscopy will be completed as normal. The procedure notes will indicated whether AI device was used or not during the procedure.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The proposed study is a randomized controlled trial to evaluate the efficacy of AI assisted colonoscopies in improving colonoscopy quality indices for gastroenterology fellows.
The subjects for this study will be the gastroenterology fellows in their first, second or third year of training. Each fellow during their VA endoscopy rotation will be randomized to perform colonoscopies using AI or following conventional methods. If randomized to AI, the endoscopy technician in the procedural room will be responsible for turning on the GI Genius software (Medtronic AI device) during the procedure. The fellow will identify whether AI was used in the procedural note documented under Provation MD software. Otherwise, all colonoscopies will be performed in the standard fashion under moderate sedation or monitored anesthesia care. Procedures will not be affected by study participation. All procedures will be performed at the Oklahoma City VA Medical Center during normal procedural times. Information such as indication for the procedure and quality indices mentioned above (such as ADR, SSLDR, withdrawal time) will be obtained from chart review and calculated using data from Provation MD retrospectively, at a later time. Other information such as patient's medical history and family history as it relates to the colonoscopy procedure will also be collected retrospectively from CPRS chart records. This will be used to exclude patients undergoing colonoscopy secondary to genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) from this study. No identifiable patient information will be saved in any format. In addition, data such as polyp size, location of polyp and histological information will be collected from CPRS charts.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- Oklahoma City VA Health Care System
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- All adult gastroenterology fellows at the University of Oklahoma, except for the fellow conducting research will be included in the study.
Exclusion Criteria:
- All patients undergoing colonoscopy for genetic cancer syndromes (ex: polyposis), inflammatory bowel disease, for therapy of known neoplasms or undergoing non-colonoscopy screening tests (fecal immunochemical test, CT colonography) will be excluded from this study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: AI assisted colonoscopy
GI fellows in this arm will complete colonoscopies with the assistance of AI device GI Genius.
|
The gastroenterology fellows assigned to AI assisted colonoscopy will use the GI genius device while performing colonoscopies.
|
|
Aktiver Komparator: Conventional colonoscopy
GI fellows in this arm will complete colonoscopy in a conventional manner
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The gastroenterology fellows assigned to conventional colonoscopy will be performing colonoscopies without the use of AI device.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Adenoma detection rate
Zeitfenster: over 18 months
|
We hypothesize that an AI assisted colonoscopy done by a gastroenterology fellow will have a higher ADR as compared to conventional colonoscopy done by the same fellow and these results will be more significant among junior fellows compared to senior fellows.
|
over 18 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sessile serrated lesion detection rate
Zeitfenster: Over 18 months
|
We hypothesize that an AI assisted colonoscopy done by a gastroenterology fellow will have a higher sessile serrated lesion detection rate as compared to conventional colonoscopy done by the same fellow and these results will be more significant among junior fellows compared to senior fellow.
|
Over 18 months
|
|
Withdrawal time
Zeitfenster: Over 18 months
|
Total withdrawal time will likely be longer in the AI assisted colonoscopy group compared to conventional colonoscopy group.
|
Over 18 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Mohammad Madhoun, University of Oklahoma
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 18531
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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