NCT06601426

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 4, 2024

Last Update Submit

September 14, 2024

Conditions

Colon Polyp

Outcome Measures

Primary Outcomes (1)

  • Histopathological complete resection rate

    2-3 days

Secondary Outcomes (1)

  • Complete recovery rate of polyps

    2-3 days

Study Arms (1)

NBI-NearFocus

OTHER

Narrow Band Imaging-NearFocus

Procedure: CSP

Interventions

CSPPROCEDURE

cold snare polypectomy

NBI-NearFocus

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Xinyong Jia

    Qianfoshan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

August 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

CN(1)