Status:
COMPLETED
Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Collaborating Sponsors:
First Affiliated Hospital of Ningbo University
Nanchong Central Hospital
Conditions:
Colorectal Adenoma
Eligibility:
All Genders
45-85 years
Phase:
NA
Brief Summary
Spectral Focused Imaging (SFI) is newly developed image-enhancing endoscopy technology that enhances the contrast of target tissue structures while improving color contrast because spectral signal ene...
Detailed Description
45-85 years-old subjects participating in their first colonoscopy and meeting all eligibility criteria are randomised 1:1 to SFI (SFI group) or WLI (WLI group) during insertion and withdrawal phase of...
Eligibility Criteria
Inclusion
- 1\. Male or female aged 45 to 85
- 2\. Patients undergoing colonoscopy for the first time due to colorectal cancer screening, having positive fecal immunochemical test (FIT) results, or experiencing gastrointestinal symptoms
- 3\. Capable of providing informed consent and agreeing to participate
- 4\. Able and willing to follow all research processes
Exclusion
- 1\. Participated in other clinical trials, signed informed consent form, and in the follow-up period of other clinical trials;
- 2\. Participated in clinical trials of drugs and is in the discontinuation period of experimental or control drugs;
- 3\. Pregnant or lactating patients;
- 4\. Known to have polyposis syndrome;
- 5\. Patients with gastrointestinal bleeding;
- 6\. Previous history of inflammatory bowel disease, colorectal cancer, or colorectal surgery;
- 7\. Patients with contraindications to tissue biopsy;
- 8\. History of allergies to the ingredients in intestinal cleansers;
- 9\. Individuals with conditions such as intestinal obstruction or perforation, toxic megacolon, heart failure (grade III or IV), severe cardiovascular disease, severe liver failure, or renal insufficiency, among others.
- 10\. Researchers believe that patients are not suitable to participate in the trial;
- 11\. Have had drug or alcohol abuse or psychological disorders in the past five years.
Key Trial Info
Start Date :
October 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2025
Estimated Enrollment :
698 Patients enrolled
Trial Details
Trial ID
NCT06603948
Start Date
October 7 2024
End Date
June 25 2025
Last Update
July 2 2025
Active Locations (8)
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1
Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100700
2
The People'S Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
3
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science
Wuhan, Hubei, China, 430000
4
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200000