Colorectal AdenomaCold-SNAPSNCT06970808
Cold Snare Versus Cold Forceps Polypectomy for Small Lesions
A study testing Sampling from the resection margins in people with Colorectal Adenoma and Colorectal Lesions, run by Azienda USL Modena at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Lesions
- What is being tested?
- Sampling from the resection margins
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years;
- Ability to provide informed consent;
- Presence of at least one colorectal polypoid/non-polypoid lesion < 10 mm
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
AUSL Modena
Carpi, Modena, 41012
Mauro Manno, Principal investigator, +39 059659250, m.manno@ausl.mo.it
About this study
Official title: Cold SNAre Versus Cold forcePS Polypectomy for Small Colorectal Lesions (Cold-SNAPS): a Multicenter Randomized Trial
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:
Read more
- 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.
Read the 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
- Being tested
- Sampling from the resection margins
- Keywords
- Cold forceps polypectomy, Colonoscopy, Cold snare polypectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling from the resection marginsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Device: Sampling from the resection margins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the procedure and immediately after the histological evaluation of the biopsy samples
Secondary outcomes (3)
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.)
Measured: Up to 30 days after the procedure
Lesion retrieval rate
Lesion retrieval rate, in relation to the resection site
Measured: 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
Measured: During the polypectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study startDec 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, Prospective, Randomized, Controlled Study
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mauro Manno, Azienda USL Modena
- Investigators
- Mauro Manno, Principal investigator, AUSL Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970808
- Sponsor's protocol ID
- 04-2025
- Acronym
- Cold-SNAPS
- Status last verified
- Apr 2025
- First submitted
- 27 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold SNAre Versus Cold forcePS Polypectomy for Small Colorectal Lesions (Cold-SNAPS): a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT06970808
- Acronym / sponsor ID
- Cold-SNAPS / 04-2025
- Conditions
- Colorectal Adenoma, Colorectal Lesions
- Keywords
- Cold forceps polypectomy, Colonoscopy, Cold snare polypectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Azienda USL ModenaUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, Prospective, Randomized, Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Cold snare polypectomy group | Active comparator | Device: Sampling from the resection marginsFor 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) |
| Cold forceps polypectomy group | Experimental | Device: Sampling from the resection marginsFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥ 18 years;
- Ability to provide informed consent;
- Presence of at least one colorectal polypoid/non-polypoid lesion < 10 mm
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling from the resection marginsAfter 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. | Device | Cold forceps polypectomy group, Cold snare polypectomy group |
Primary outcome
Incomplete resection rate
Time frame: Immediately after the procedure and immediately after the histological evaluation of the biopsy samples
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.
3 secondary outcomes
Adverse events
Time frame: Up to 30 days after the procedure
Lesion retrieval rate
Time frame: During the polypectomy
Polypectomy duration
Time frame: During the polypectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mauro Manno principal investigator
AUSL Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling from the resection margins in people with Colorectal Adenoma and Colorectal Lesions, run by Azienda USL Modena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemi Gualandi (+39 059659500, gualandinoemi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incomplete resection rate (time frame: Immediately after the procedure and immediately after the histological evaluation of the biopsy samples). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.