Cold Snare Versus Cold Forceps Polypectomy for Small Lesions

NCT06970808 | Not Yet Recruiting

• 1 other identifier: 04-2025
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cold forceps polypectomy; Colonoscopy; Cold snare polypectomy

Outcome Measures

Primary Outcomes (1)

• Incomplete resection rate

  Compare the rate of incomplete endoscopic resection (IER) of CFP and CSP, defined as the presence of residual adenomatous tissue in the biopsy samples of the margins or after the visual assessment of the resection base.

  Immediately after the procedure and immediately after the histological evaluation of the biopsy samples

Secondary Outcomes (3)

• Adverse events

  Up to 30 days after the procedure

• Lesion retrieval rate

  During the polypectomy

• Polypectomy duration

  During the polypectomy

Study Arms (2)

Cold snare polypectomy group

ACTIVE COMPARATOR

For CSP, a 10 mm cold snare will be used (cold snare, Boston Scientific Corporation®, Marlborough, Massachusetts and cold snare, Meditalia S.A.S.®, Palermo, Italy); for CFP, a dedicated forceps will be used (Leviathan® cold forceps, 10 mm opening; Meditalia S.A.S., Palermo, Italy)

Device: Sampling from the resection margins

Cold forceps polypectomy group

EXPERIMENTAL

For CFP, Leviathan® will be used (Meditalia S.A.S., Palermo, Italy). The opening jaw reaches a 10 mm diameter, and the central section of each jaw has an enlarged diameter up to 3.6 mm compared to the oval axis, enhancing its capacity

Device: Sampling from the resection margins

Interventions

Sampling from the resection margins DEVICE

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.

Cold forceps polypectomy group; Cold snare polypectomy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years;
• Ability to provide informed consent;
• Presence of at least one colorectal polypoid/non-polypoid lesion \< 10 mm

You may not qualify if:

• Primary or secondary coagulopathy;
• Improper interruption of dual antiplatelet therapy and/or antiplatelet therapy with P2Y12 receptor antagonists (clopidogrel, prasugrel, ticagrelor) and/or anticoagulant therapy;
• Chronic inflammatory bowel diseases;
• Inpatients undergoing colonoscopy;
• Colonoscopy as part of regional colorectal cancer screening;
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Azienda USL Modena: lead

Study Sites (1)

AUSL Modena

Carpi, Modena, 41012, Italy

Location

Study Officials

• Mauro Manno

  AUSL Modena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Noemi Gualandi

CONTACT

+39 059659500; gualandinoemi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only the medical staff who will assess for possible complications, by calling patients 30 days post-polypectomy, will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology and Endoscopy Unit director

Model Details: Multicenter, Prospective, Randomized, Controlled Study

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 14, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-04

Locations

IT (1)