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Trial Title:
Spectral Focused Imaging Versus White Light Imaging in Colorectal Adenoma Detection
NCT ID:
NCT06603948
Condition:
Colorectal Adenoma
Conditions: Official terms:
Adenoma
Conditions: Keywords:
Spectral Focused Imaging
Colorectal adenoma
ADR
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Spectral Focused Imaging
Description:
Use of SFI for colon inspection during both insertion and withdrawal phase of colonoscopy
Arm group label:
SFI
Intervention type:
Device
Intervention name:
White Light Imaging
Description:
Use of WLI for colon inspection during both insertion and withdrawal phase of colonoscopy
Arm group label:
WLI
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 energy is further concentrated on the absorption peak wavelength
of microvessels by using digital spectral processing techniques. This technology,
combined in the latest generation SonoScape's endoscopes (SonoScape Co, Shenzhen,
China) with new high-performance LED illumination system, enhances the visibility of
colonic mucosal vessels and might increase the detection rate of colorectal polyps. Data
available regarding colorectal polyp or adenoma detection with SFI are encouraging but
are scanty and limited to back-to back studies.
This two parallel arms, randomized, multicenter trial is aimed at evaluating whether SFI
is superior to WLI endoscopy in terms of adenoma detection
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 colonoscopy. All procedures are performed with a
high-definition HD-580 series videocolonscopes with or without magnification (SonoScape
Co, Shenzhen, China).
The primary outcome measure is the ADR, defined as the proportion of participants with at
least one adenoma (per-patient analysis).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
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 Criteria:
-
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.
Gender:
All
Minimum age:
45 Years
Maximum age:
85 Years
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Fujian Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Ningbo University
Agency class:
Other
Collaborator:
Agency:
Nanchong Central Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Xinjiang Medical University
Agency class:
Other
Collaborator:
Agency:
West China Forth Hospital
Agency class:
Other
Collaborator:
Agency:
People's Hospital of Guangxi
Agency class:
Other
Collaborator:
Agency:
Seventh Medical Center of PLA Army General Hospital
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Agency class:
Other
Collaborator:
Agency:
The Second Affiliated Hospital of Chongqing Medical University
Agency class:
Other
Collaborator:
Agency:
People's Hospital of Rizhao Lanshan
Agency class:
Other
Collaborator:
Agency:
Taicang First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Lingshan people's Hospital
Agency class:
Other
Collaborator:
Agency:
Songming People's Hospital
Agency class:
Other
Collaborator:
Agency:
The People's hospital of wanzai county
Agency class:
Other
Collaborator:
Agency:
Xiangning People's Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan Central Hospital
Agency class:
Other
Collaborator:
Agency:
The First Hospital of Hunan University of Chinese Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06603948
