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임상시험 NCT06970808 (Cold-SNAPS)은(는) 대장직장 선종, 대장 병변에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Cold Snare Versus Cold Forceps Polypectomy for Small Lesions (Cold-SNAPS) 312 무작위 배정 교차 설계
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06970808 (Cold-SNAPS)은(는) 대장직장 선종, 대장 병변에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2025년 12월 1일부터 참여 신청이 가능합니다. 312명의 참여자를 모집할 예정입니다. Azienda USL Modena이(가) 진행하는 이 연구는 2027년 12월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 5월 14일에 갱신되었습니다.
간단한 개요
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...
상세한 설명
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...
더 보기공식 제목
Cold SNAre Versus Cold forcePS Polypectomy for Small Colorectal Lesions (Cold-SNAPS): a Multicenter Randomized Trial
질환명
대장직장 선종대장 병변기타 연구 식별자
- Cold-SNAPS
- 04-2025
NCT 번호
실제 연구 시작일
2025-12
최신 업데이트 게시
2025-05-14
예상 연구 완료일
2027-12
계획된 등록 인원
312
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
Cold forceps polypectomy
Colonoscopy
Cold snare polypectomy
Colonoscopy
Cold snare polypectomy
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
활성 대조군Cold 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. |
실험적Cold 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. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- 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 Modena연구 책임자
Dr. Mauro Manno, 책임연구자, Gastroenterology and Endoscopy Unit director, Azienda USL Modena
연구 대표 연락처
연락처: Noemi Gualandi, +39 059659500, [email protected]
1 1개국에 임상시험 장소
Modena
AUSL Modena, Carpi, Modena, 41012, Italy
Mauro Manno, Principal investigator, 연락처, +39 059659250, [email protected]