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Clinical Trial NCT06970808 (Cold-SNAPS) for Colorectal Adenoma, Colorectal Lesions is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Cold Snare Versus Cold Forceps Polypectomy for Small Lesions (Cold-SNAPS) 312 Randomized Crossover Design

Not yet recruiting
Clinical Trial NCT06970808 (Cold-SNAPS) is an interventional study for Colorectal Adenoma, Colorectal Lesions and is currently not yet recruiting. Enrollment is planned to begin on 1 December 2025 and continue until the study accrues 312 participants. Led by Azienda USL Modena, this study is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 14 May 2025.
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 cou...
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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 contacte...

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Official Title

Cold SNAre Versus Cold forcePS Polypectomy for Small Colorectal Lesions (Cold-SNAPS): a Multicenter Randomized Trial

Conditions
Colorectal AdenomaColorectal Lesions
Other Study IDs
  • Cold-SNAPS
  • 04-2025
NCT ID Number
NCT06970808
Start Date (Actual)
2025-12
Last Update Posted
2025-05-14
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
312
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Cold forceps polypectomy
Colonoscopy
Cold snare polypectomy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorCold 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)
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.
ExperimentalCold 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
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Adverse events
Intraprocedural bleeding (i.e., post-polypectomy "spurting" or "oozing" bleeding lasting more than one minute of observation, requiring hemostatic interventions) and delayed bleeding (within 30 days of the procedure, requiring a second endoscopic treatment and/or hospitalization); perforation (intraprocedural or delayed), defined as grade III (damage to the muscular layer with recognition of the "target sign") or grade IV/V (full-thickness perforation of the bowel wall with or without contamination, respectively) according to the Sydney Classification. All patients will be contacted, 30 days post-polypectomy, by blinded medical staff assessing for possible complications (rectal bleeding, abdominal pain, hospitalization due to perforation/bleeding, etc.)
Up to 30 days after the procedure
Lesion retrieval rate
Lesion retrieval rate, in relation to the resection site
During the polypectomy
Polypectomy duration
Polypectomy duration evaluated in seconds: the time will be calculated from the exit of the device from endoscopic channel to the lesion retrieval. Cold forceps polypectomy is assumed to have a shorter procedural time, reducing the overall colonoscopy duration, improving patient compliance, and reducing the sedation required, with fewer risks related to sedation
During the polypectomy
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • Patients aged ≥ 18 years;
  • Ability to provide informed consent;
  • Presence of at least one colorectal polypoid/non-polypoid lesion < 10 mm

  • 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
Azienda USL Modena logoAzienda USL Modena
Study Responsible Party
Dr. Mauro Manno, Principal Investigator, Gastroenterology and Endoscopy Unit director, Azienda USL Modena
Study Central Contact
Contact: Noemi Gualandi, +39 059659500, [email protected]
1 Study Locations in 1 Countries

Modena

AUSL Modena, Carpi, Modena, 41012, Italy
Mauro Manno, Principal investigator, Contact, +39 059659250, [email protected]