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NCT06924489 | NOT YET RECRUITING | Colorectal Adenoma

Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy
Sponsor:

Xijing Hospital of Digestive Diseases

Information provided by (Responsible Party):

Z Hi L IU

Brief Summary:

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.

Condition or disease

Colorectal Adenoma

Colorectal Polyps

Intervention/treatment

Colonoscopy after bowel cleansing with 2D imaging device

Colonoscopy after bowel cleansing with 3D imaging device

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 1566 participants
Masking : DOUBLE
Primary Purpose : DIAGNOSTIC
Official Title : Effect of 3-Dimensional Imaging Device on Advanced Adenoma Detection During Colonoscopy: A Multi-center Randomized Controlled Trial
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-06-01
Estimated Study Completion Date : 2026-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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;
Exclusion Criteria
  • * 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;
  • * 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 toxic megacolon;
  • * 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;
  • * Patients with intestinal strictures of any cause;
  • * Pregnancy and lactation.
Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

Location Details

NCT06924489

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