Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-08

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to correctly classify colon polyps and adenomas during colonoscopy to guide the selection of proper treatment procedures. 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 correct classification as well as size and depth evaluation of polyps and adenomas during colonoscopy using pathology as gold standard? What adverse events do participants experience during colonoscopy and polypectomy?

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 classification and evaluation accuracy.

Participants will:

Undertake colonoscopy examination and polypectomy 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

NCT06924489

Colorectal Adenoma Colorectal Polyps

NOT_YET_RECRUITING NA

Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group

NCT06678477

Adenoma Detection Rate Colonoscopy Three Dimensional +1 more

RECRUITING NA

A Clinical Trial of the Effectiveness and Safety of Software Assisting Diagnose the Intestinal Polyp Digestive Endoscopy by Analysis of Colonoscopy Medical Images From Electronic Digestive Endoscopy Equipment

NCT05687318

Artificial Intelligence Enteroscope Intestinal Polyposis, Adenomatous

COMPLETED NA

Impact of Automatic Polyp Detection System on Adenoma Detection Rate

NCT03967756

Colonic Polyps Colorectal Adenomas

UNKNOWN NA

Detection and Classification of Colon Polyps

NCT00825292

Colon Polyps

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Polyps Colorectal Adenomas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

2D imaging arm

participants will undergo polypectomy (CSP, CFP, or EMR) using 2D imaging colonoscope

Group Type ACTIVE_COMPARATOR

endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope

Intervention Type DIAGNOSTIC_TEST

endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 2D imaging colonoscope

3D imaging arm

participants will undergo polypectomy (CSP, CFP, or EMR) using 3D imaging colonoscope

Group Type EXPERIMENTAL

endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope

Intervention Type DIAGNOSTIC_TEST

endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 3D imaging colonoscope

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope

endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 2D imaging colonoscope

Intervention Type DIAGNOSTIC_TEST

endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope

endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 3D imaging colonoscope

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged over 18 years;
* Endoscopically diagnosed with colorectal polyps;
* Signing the written informed consent.

Exclusion Criteria

* Patients with mental illness or severe functional disorder who cannot cooperate with colonoscopy;
* Patients with severe cardiopulmonary insufficiency;
* Patients with severe coagulation disorders or high bleeding risk (platelets \<50×10⁹/L, INR \>1.5; discontinuation of antithrombotic drugs should follow the 2012 Japanese Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment and the2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants;
* Patients with severe electrolyte imbalances;
* Patients with acute peritonitis or suspected intestinal perforation;
* Patients with severe inflammatory bowel disease/toxic megacolon;
* Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis \[FAP\], Lynch syndrome, etc.);
* Patients with stage 3 or higher hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
* Patients with untreated severe abdominal hernia, intestinal obstruction, or advanced colorectal cancer;
* Patients with intestinal strictures of any cause;
* Cases requiring only endoscopic submucosal dissection (ESD);
* Pregnancy and lactation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No