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De klinische studie NCT06251700 (ENDOAID-PRO) voor Screening Colonscopy is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Chinese University of Hong KongLongterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence (ENDOAID-PRO) 775
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De klinische studie NCT06251700 (ENDOAID-PRO) is een interventioneel studie bij Screening Colonscopy met de status rekruterend. Het doel is om 775 deelnemers te includeren vanaf 24 januari 2024. De studie wordt geleid door Chinese University of Hong Kong en de voltooiing is gepland op 30 april 2027. Laatste update op ClinicalTrials.gov: 29 oktober 2024.
Beknopte samenvatting
We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.
Uitgebreide beschrijving
Between April 2021 and July 2022, our group completed a parallel-group, randomized controlled trial in Hong Kong. \[ENDOAID-TRAIN study; NCT04838951\] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID, Olympus Co., Japan) or standard colonoscopies (control). Our study proved that AI-assisted colonoscopies could increase the overall ADR, especially small-to-medium s...Toon meer
Officiële titel
Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial
Aandoeningen
Screening ColonscopyAndere studie-ID's
- ENDOAID-PRO
- 2023.541
NCT-ID
Startdatum (Werkelijk)
2024-01-24
Laatste update geplaatst
2024-10-29
Verwachte einddatum
2027-04-30
Inschrijving (Geschat)
775
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelIntervention arm CADe system will be used during withdrawal phase of colonscopy | ENDO-AID CADe ENDO-AID CADe will be used during the withdrawal process of the colonscopy |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Post-colonoscopy adenomas at year 3 | The primary endpoint is the incidence of post-colonoscopy adenomas at year 3, which is the composite of new occurrence and metachronous recurrence of adenomas during surveillance. | During the colonoscopy |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Post-colonoscopy AA | Incidence of post-colonoscopy advanced adenomas | During the colonoscopy |
Post-colonoscopy advanced neoplasms | Incidence of post-colonoscopy advanced neoplasms | During the colonoscopy |
Post-colonoscopy SSL | Incidence of post-colonoscopy SSL | During the colonoscopy |
Post-colonoscopy CRC | Incidence of post-colonoscopy CRC | During the colonoscopy |
Post-colonoscopy adenomas and advanced adenomas | Number of post-colonoscopy adenomas and advanced adenomas | During the colonoscopy |
Size and location of post-colonoscopy adenomas and advanced adenomas | Size and location of post-colonoscopy adenomas and advanced adenomas | During the colonoscopy |
High-risk and low-risk group according to USMSTF guideline | Proportion of subjects re-classified as high-risk and low-risk groups according to USMSTF guideline | During the colonoscopy |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Subjects are eligible if:
(i) They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study \[NCT04838951\]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained.
Subjects will be excluded from the study if they have any of the followings:
(i) Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.
Chinese University of Hong Kong474 actieve klinische studies om te verkennenVerantwoordelijke instantie
Louis Ho Shing Lau, Hoofdonderzoeker, Assistant Professor, Chinese University of Hong Kong
Centraal Contactpersoon
Contact: Felix Sia, 26370428, [email protected]
1 Studielocaties in 1 landen
Prince of Wales Hospital, Hong Kong, Hong Kong
Louis Lau, Contact
Rekruterend