ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT07005453 (ASSEMBLE) के लिए Colorectal Polyps वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size (ASSEMBLE) 241 रैंडमाइज़्ड
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT07005453 (ASSEMBLE) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो Colorectal Polyps से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 23 सितंबर 2025 को हुई थी, और इसमें कुल 241 प्रतिभागियों के नामांकन की योजना है। Erasmus Medical Center इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 अप्रैल 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 13 जनवरी 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population.
Sustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.
विस्तृत विवरण
Objective: This study aims to assess the diagnostic performance of SCALE-EYE in a screening and surveillance colonoscopy population. Also, sustainability of SCALE-EYE in terms of the reduction in colonoscopies, associated waste and carbon footprint is evaluated.
Study design: A multicenter, randomized, parallel group, endoscopist blinded study.
Study population: The unit of analysis is the colorectal polyp rather t...
और दिखाएँआधिकारिक शीर्षक
Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy
स्वास्थ्य स्थितियां
Colorectal Polypsअन्य अध्ययन आईडी
- ASSEMBLE
- MEC-2024-0789
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2025-09-23
अंतिम अद्यतन प्रकाशित
2026-01-13
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-04-01
नामांकन (अनुमानित)
241
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
भर्ती जारी
प्रमुख शब्द
virtual scale endoscopy
biopsy forceps
optical assessment
colorectal cancer
biopsy forceps
optical assessment
colorectal cancer
प्राथमिक उद्देश्य
निदानात्मक
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
अन्यSCALE-EYE measurement than biopsy-forceps assisted measurement When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by SCALE-EYE measurement and afterwards by biopsy-forceps assisted measurement. | SCALE-EYE (1) Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then with SCALE-EYE and lastly by biopsy-forceps assisted measurement. |
अन्यBiopsy-forceps assisted measurement than SCALE-EYE measurement When colorectal polyps are identified, then first the polyp size is categorized by optical assessment by the endoscopist. Then the polyp size is categorized by biopsy-forceps assisted measurement and afterwards by SCALE-EYE measurement. | SCALE-EYE (2) Participants will undergo the colonoscopy and once a colorectal polyp is identified, the polyp will first be measured by optical assessment by the endoscopist, then by biopsy-forceps assisted measurement and lastly with SCALE-EYE. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
SCALE-EYE diagnostic performance versus biopsy-forceps | The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to polyp size categorization with biopsy-forceps assisted measurement (the reference standard). This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to size measurement with the reference standard. | Immediately after the screening and/or surveillance colonoscopy |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
SCALE-EYE diagnostic performance versus optical assessment | The diagnostic performance of SCALE-EYE for polyp size categorization during real-time colonoscopy in comparison to optical assessment for polyp size measurement. This will be measured by accuracy, sensitivity, and specificity of SCALE-EYE categorization compared to optical assessment. | Immediately after the screening and/or surveillance colonoscopy |
Sustainability | The sustainability aspect of SCALE-EYE will be assessed by exploring whether the number of colonoscopies, the colonoscopy-associated waste and carbon footprint will be reduced by correct size measurement. | After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy) |
Learning curve | The learning curve will be evaluated by exploring the association between the number of measurements performed and the time needed for measurement and experienced difficulty. | Immediately after the screening and/or surveillance colonoscopy |
Surveillance interval agreement | The level of agreement between the endoscopist advised surveillance interval as based on SCALE-EYE, optical assessment, and the reference standard (biopsy-forceps assisted measurement) will be compared. | After the screening and/or surveillance colonoscopy when the endoscopist advised surveillance interval is known (on average 30 days post-colonoscopy) |
(Serious) adverse events | Serious adverse events (SAEs) and adverse events (AEs) will be summarized by proportions. | Up to 30 days post-colonoscopy |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
55 Years
अध्ययन के लिए पात्र लिंग
सभी
- Participants aged 55-80
- Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy
- Polyps of all forms ≤25 mm as assessed by the endoscopist
- No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present
- Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) <2 per segment)
- Intraprocedural complications, not caused by the study device
- Known or suspected inflammatory bowel disease (IBD)
- Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis)
- Ileoanal pouch and anastomosis
- History of radiation or chemotherapy for colorectal lesions
- Scheduled for therapeutic procedure (for example intervention to stop a lower gastro-intestinal bleeding, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD))
- Pregnancy
- No Informed consent (IC) possible
Erasmus Medical Centerअध्ययन उत्तरदायी पक्ष
Peter Siersema, मुख्य अन्वेषक, Prof. Dr. P.D. Siersema, Erasmus Medical Center
कोई संपर्क डेटा नहीं।
3 1 देशों में अध्ययन स्थान
North Brabant
Catharina Ziekenhuis, Eindhoven, North Brabant, 5623 EJ, Netherlands
Ramon-Michel Schreuder, Dr., संपर्क, +31 40 2399750, [email protected]
भर्ती जारी
South Holland
LUMC, Leiden, South Holland, 2333 ZG, Netherlands
Jurjen Boonstra, Dr., संपर्क, +31 71 5263575, [email protected]
भर्ती जारी
Erasmus MC, Rotterdam, South Holland, 3015 GD, Netherlands
Demi Gerritsen, MSc, संपर्क, +31 650033985, [email protected]
भर्ती जारी