MedTrace Logo

Cold Snare Versus Cold Forceps Polypectomy for Small Lesions

NCT06970808 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2025-05-14

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the efficacy and the safety of a new device for cold forceps polypectomy (CFP)- a special jumbo forceps- to cold snare polypectomy (CSP) for small colorectal lesions, without adding peri- or post-procedural risks to the patient.

The main questions it aims to answer are:

* Does the cold forceps guarantee a complete endoscopic resection rate?
* How many adverse events could the jumbo forceps reduce in comparison to CSP?
* Does the lesion retrieval rate increase?
* Does the polypectomy duration decrease? Participants will be randomized to one or to the other group when a polypoid or non-polypoid lesion is identified. If multiple polyps are found in the same patient, they will be removed using the same polypectomy technique.

If polypectomy cannot be performed using the indicated technique, a crossover will be done according to the best practice of care principles.

Conditions

  • Colorectal Adenoma
  • Colorectal Lesions

Interventions

DEVICE

Sampling from the resection margins

After polypectomy, the base will be irrigated and assessed by the endoscopist, who may also use virtual or vital chromoendoscopy, if needed. Any residual adenomatous tissue will be removed using the same technique. To confirm the completeness of each polypectomy, two biopsies will be taken from the resection margins for polyps ≤ 5 mm, and three biopsies for polyps 6-9 mm, using standard biopsy forces.

Sponsors & Collaborators

  • Azienda USL Modena

    lead OTHER

Principal Investigators

  • Mauro Manno · AUSL Modena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970808 on ClinicalTrials.gov