An interventional study of Sampling from the resection margins in Colorectal Adenoma and Colorectal Lesions, sponsored by Azienda USL Modena. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Azienda USL Modena · Not applicable, Interventional, and Treatment
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:
If polypectomy cannot be performed using the indicated technique, a crossover will be done according to the best practice of care principles.
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".
Azienda USL Modena is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Time frame: Immediately after the procedure and immediately after the histological evaluation of the biopsy samples
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.)
Time frame: Up to 30 days after the procedure
Lesion retrieval rate
Lesion retrieval rate, in relation to the resection site
Time frame: 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
Time frame: During the polypectomy
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2025; primary completion for Oct 2027, 22 months later.
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Azienda USL Modena