NBI-NearFocus Assisted Cold Snare Polypectomy Improves the Complete Resection Rate of Small Colorectal Polyps: a Prospective Single-arm Observational Study

September 14, 2024 updated by: Xinyong Jia, Qianfoshan Hospital
NBI-NearFocus can assist cold snare polypectomy (CSP) to remove small colorectal polyps, but its specific efficacy is not clear.The aim of this study was to assess the efficacy of CSP with NBI-NearFocus evaluation of polypectomy sites for removal of small colorectal polyps. And then formulate a standard operating procedure for cold snare removal of polyps.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250014
        • Qianfoshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

① Outpatient or inpatient patients aged 18-85 years old;

② Untamed, subpodial, and flat polyps with a diameter of 5-9mm (Paris classification: O-Is O-Isp、O-IIa；JNET Classification: Typel, Type2A);

③ Patients who agree to participate in this study.

Exclusion Criteria:

  • Individuals currently taking antiplatelet or anticoagulant drugs, or those with coagulation dysfunction (PT prolongation greater than 3 seconds);

    • Polyp diameter<5mm or ≥ 10mm, morphology does not conform or JNET classification ≥ Type 2B;

      • Individuals with severe heart, lung, liver and kidney dysfunction or severe mental disorders who cannot cooperate with the examination; ④ Patients with intestinal obstruction, inflammatory bowel disease, Lynch syndrome, and familial adenomatous polyposis diagnosis;

        • Pregnancy; ⑥ Those who fail to meet the requirements for bowel cleansing preparation (BBPS<6 points).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NBI-NearFocus
Narrow Band Imaging-NearFocus
Procedure: CSP
cold snare polypectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histopathological complete resection rate
Time Frame: 2-3 days
2-3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Complete recovery rate of polyps
Time Frame: 2-3 days
2-3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qianfoshan Hospital

Investigators

  • Principal Investigator: Xinyong Jia, Qianfoshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

September 4, 2024

First Submitted That Met QC Criteria

September 14, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 14, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 147258368

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colon Polyp

Clinical Trials on CSP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe