Építés alatt – nem éles oldal
Belépés

NCT07844252Toborzás még nem indult

A Novel Multi-functional Artificial Intelligence System on Treatment Efficacy and Implementation in Colonoscopy

A Novel Multi-functional Artificial Intelligence System on Treatment Efficacy and Implementation in Colonoscopy: an International Multicenter Randomized Controlled Trial

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 28.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

To overcome non-neoplastic polyp (NNP) resections, computer-aided diagnosis (CADx) systems have been developed. In a meta-analysis, the performance of CADx systems was superior to endoscopists. The proportion of incorrect predictions could be significantly reduced with CADx assistance. It was reported that autonomous AI prediction could achieve an agreement with the standard pathology-based surveillance intervals. In a prospective study targeting diminutive rectosigmoid polyps, CADx achieved a negative predictive value compared to the histology as gold standard. Lesions were amendable for a leave-in-situ strategy, suggesting a potential to reduce the burden of unnecessary polypectomies. It was estimated that the average colonoscopy cost and annual reimbursement could be reduced under the 'diagnose-and-leave' strategy. Nevertheless, almost all existing literature reporting the efficacy of CADx were simulated studies and focused on the diagnostic accuracy (i.e. all polyps were ultimately resected for histopathology). There is a lack of real-world data with hard clinical endpoints to support its implementation. A recent RCT compared leave-in-situ and resect-all strategy with real-time CADx in both arms. Using ADR as the surrogate marker, it was shown that the leave-in-situ strategy with CADx support was non-inferior. The major limitations of this RCT were that: i) CADx were activated in both arms - the pure CADx effect could not be demonstrated; ii) 'resect-all' strategy was not a real-world practice especially for diminutive rectosigmoid polyps; iii) the interaction and decision making between AI and human was not documented and uncertain. A well-designed RCT is warranted to evaluate the pure CADx effect on reducing NNP resections (enhance treatment efficacy) while maintaining the benchmark of ADR (safe implementation). In addition, AI-measured metrics may objectively validate the procedural quality for performance tracking and auditing purposes. If the above points are proven, AI-assisted colonoscopy would become the 'mainstream' in CRC prevention.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
2818 (tervezett)
Első benyújtás
2026. szept. 8.
Kezdés
2026. okt. 30.
Elsődleges befejezés
2028. dec. 31.
Fő szponzor
Chinese University of Hong Kong
Betegségek
Vastagbélrák
NCT-szám
NCT07844252

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 2818
  • 2026. okt. 30. és az elsődleges befejezés (2028. dec. 31.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

  • Prior surgical resection of colon;

Más betegség

  • Contraindication for polypectomy (e.g. active gastrointestinal bleeding, uninterrupted anticoagulants);
  • High-risk group of CRC (e.g. personal history of CRC, familial polyposis syndrome, inflammatory bowel disease);

Egyéb

  • Contraindication for colonoscopy (e.g. intestinal obstruction);
  • Advanced comorbidity (defined as American Society of Anesthesiologists grade 4 or above).

Kiket keres a vizsgálat

  • Aged 45-85 years old;
  • Undergoing elective colonoscopy for screening, surveillance or diagnostic indication;
  • Informed consented.

Életkor a regiszterben: 45 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad

A teljes feltétellista: ClinicalTrials.gov

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.