Cold Snare Versus Cold Forceps Polypectomy for Small Lesions

NCT ID: NCT06970808

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2027-12-31

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.

Detailed Description

The study is a Multicenter, Prospective, Randomized, Controlled Study. It is designed as a non-inferiority trial to assess whether the efficacy in polypectomy of the new jumbo cold forceps is non-inferior to that of the cold snare.

The investigators hypothesize a less number of adverse events with CFP, an increased lesion retrieval rate and a less duration of the polypectomy procedure.

All patients will be contacted, 30 days post-polypectomy, by blinded medical staff assessing for possible complications.

All consecutive patients with polyp lesions can be enrolled, the participation is voluntary and randomization will be performed using the "minimization technique".

Conditions

Colorectal Adenoma; Colorectal Lesions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cold snare polypectomy group

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)

Group Type: ACTIVE_COMPARATOR

Sampling from the resection margins

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Sampling from the resection margins

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda USL Modena

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mauro Manno

Gastroenterology and Endoscopy Unit director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro Manno

Role: PRINCIPAL_INVESTIGATOR

AUSL Modena

Locations

AUSL Modena

Carpi, Modena, Italy

Countries

Italy

Central Contacts

Noemi Gualandi

Role: CONTACT

gualandinoemi@gmail.com

+39 059659500

Facility Contacts

Mauro Manno, Principal investigator

Role: primary

m.manno@ausl.mo.it

+39 059659250

Other Identifiers

04-2025

Identifier Type: -

Identifier Source: org_study_id