Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXijing Hospital of Digestive Diseases
About this trial
The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are:
Does 3-dimensional (3D) imaging device improve the identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve high risk adenoma identification.
Participants will:
Undertake colonoscopy examination using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device. Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.
Eligibility criteria
Qualifiers
Aged 18-75 years;
Patients with indications for colonoscopy and receiving diagnostic colonoscopy, without history of inflammatory bowel disease, colorectal cancer, polypectomy or polyposis syndromes;
Signing the written informed consent;
Disqualifiers
Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis [FAP], Lynch syndrome, etc.);
Patients with a history of colorectal polypectomy and pathological diagnosed as adenoma;
Patients with a history of colorectal adenocarcinoma or alarming symptoms;
Patients with a history of inflammatory bowel disease;
Trial design
Treatments tested in this trial
- Colonoscopy after bowel cleansing with 2D imaging device
- Colonoscopy after bowel cleansing with 3D imaging device
Treatment groups
1,566 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xijing Hospital of Digestive Diseases
Lead sponsor
Beijing Friendship Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Source ClinicalTrials.gov