رادار التجارب AI | ||
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حالة التجربة السريرية NCT05244278 لـ الذكاء الاصطناعي هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies ١٬٥٩٦ عشوائية مزدوجة التعمية
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT05244278 هي دراسة تدخُّلية لـالذكاء الاصطناعي وهي يقبل مشاركين. بدأت في ١٤ محرم ١٤٤٥ هـ مع خطة لتجنيد ١٬٥٩٦ مشاركًا. يقودها Centre hospitalier de l'Université de Montréal (CHUM)، ومن المتوقع اكتمالها بحلول ٢٣ رجب ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٥ رمضان ١٤٤٦ هـ.
الملخص
This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a Computer-assisted detection (CADe) system within the routine clinical practice of Canadian healthcare institutions.
The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.
وصف مفصل
This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.).
Eligible patients will be randomized (1:1) stratified per center, endoscopist, sex, and age group in two arms...
عرض المزيدالعنوان الرسمي
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
الحالات الطبية
الذكاء الاصطناعيمعرّفات دراسة أخرى
- 2022-10312, 21.297
NCT معرّف
تاريخ البدء (فعلي)
2023-08-01
آخر تحديث مُنشور
2025-03-05
تاريخ الاكتمال (المقدر)
2027-01-01
عدد المشاركين المخطط لهم
١٬٥٩٦
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
يقبل مشاركين
الكلمات الرئيسية
Polyp detection
Adenoma detection
Adenoma per colonoscopy
Sessile serrated lesion detection rate
Sessile serrated lesion per colonoscopy
Adenoma detection
Adenoma per colonoscopy
Sessile serrated lesion detection rate
Sessile serrated lesion per colonoscopy
الغرض الأساسي
تشخيصي
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
ثلاثي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةOperating room equipped with the CADe (Medtronic-GI genius for real-time detection) The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. | Medtronic-GI genius (CADe system for detecting colorectal polyps) Medtronic-GI genius: AI will provide real-time feedback throughout each colonoscopy procedure and alert endoscopists to the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. |
بدون تدخلColonoscopy performed in room without CADe system In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules. | غ/م |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
ADR | The adenoma detection rate (ADR) is defined as the proportion of colonoscopies with at least 1 histopathologically proven adenoma or carcinoma detected. | 30 days |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Mean number of adenomas per colonoscopy (APC) | Mean number of adenomas per colonoscopy (APC) defined as the total number of adenomas divided by the number of colonoscopies performed | 30 days |
Sessile serrated lesions (SSL) detection rate | Sessile serrated lesions (SSL) detection rate as the proportion of patients colonoscopy in whom superior or equal to 1 sessile serrated lesion (SSL) is identified | 30 days |
Sessile serrated lesion per Colonoscopy (SSLPC) | Sessile serrated lesion per Colonoscopy (SSLPC), defined as the total number of histologically confirmed sessile serrated lesions resected divided by the total number of colonoscopies | 30 days |
Advanced lesion detection rate (ALDR) | Advanced lesion detection rate (ALDR), defined as the proportion of colonoscopies for which the number of histopathologically proven adenoma \>10mm was at least 1. | 30 days |
Proximal ADR | Proximal ADR is defined as the prevalence of patients with at least 1 adenoma detected proximal to the splenic flexure | 30 days |
Proportion neoplastic and non-neoplastic polyps | Proportion neoplastic and non-neoplastic polyps (i.e., SSLs, hyperplastic polyps, and high-grade dysplasia and carcinomas (overall and according to size, location, and morphology) | 30 days |
CADe utilization rate | CADe utilization rate (when available in the room). Since the CADe utilization rate cannot be assessed without revealing the ongoing trial to the endoscopists, two voluntary self-reported measures and a partially objective measure. First, endoscopists will be surveyed via email during and at the end of the trial regarding their use of CADe, while keeping them unaware of the ongoing trial. Second, the proportion with endoscopy reports for which is is explicitly stated that CADe was used will be computed. | Through study completion, an average of 3 years |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
45 Years
الجنس المؤهل
الكل
- indication of undergoing a screening, surveillance, or diagnostic colonoscopy
- Age 45-89 years
- Patients undergoing emergency colonoscopy
- Patients with a known familial polyposis syndrome or a known inflammatory bowel disease
Centre hospitalier de l'Université de Montréal (CHUM)الجهة المسؤولة عن الدراسة
Daniel Von Renteln, المحقق الرئيسي, Gastroenterologist, Principal Scientist, MD, PhD, Centre hospitalier de l'Université de Montréal (CHUM)
لا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
Quebec
Centre Hospitalier Universitaire de Montréal, Montreal, Quebec, Canada
Samira Hanin, جهة اتصال, 514-890-8000, [email protected]
Daniel von Renteln, MD, PhD, المحقق الرئيسي
يقبل مشاركين