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임상시험 NCT06855485 (ZEUS)은(는) 췌장 가성낭종에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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서울아산병원Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage (ZEUS) 20 관찰 연구
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임상시험 NCT06855485 (ZEUS)은(는) 췌장 가성낭종에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 2월 25일에 시작되어 20명의 참여자를 모집하고 있습니다. 서울아산병원이(가) 진행하며, 2025년 12월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 3월 3일에 갱신되었습니다.
간단한 개요
The goal of this prospective, single-center observational study is to evaluate the safety and effectiveness of the HANAROSTEN® HOT Plumber™ with Z-EUSIT™ for draining pancreatic pseudocysts.
The main questions the study aims to answer are:
- Does the device reduce the size of pancreatic pseudocysts by at least 50% and improve associated symptoms within 30 to 60 days?
- Can the stent be successfully placed, retained...
상세한 설명
Detailed Description
This prospective, single-center observational study aims to evaluate the safety and effectiveness of the HANAROSTEN HOT Plumber with Z-EUSIT for pancreatic pseudocyst drainage. The study will assess clinical success, defined as a reduction of at least 50% in pseudocyst size accompanied by symptom improvement, as well as technical success, device retention, lumen patency, and adverse events. Foll...
더 보기공식 제목
A Prospective Single-Center Observational Study on the Evaluation of Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocysts Drainage
질환명
췌장 가성낭종기타 연구 식별자
- ZEUS
- ZEUS-PPD-001
NCT 번호
실제 연구 시작일
2025-02-25
최신 업데이트 게시
2025-03-03
예상 연구 완료일
2025-12-30
계획된 등록 인원
20
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Pancreatic Pseudocyst
Endosonography
Drainage
Stents
Endosonography
Drainage
Stents
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Single Intervention Group Participants will undergo endoscopic ultrasound-guided drainage of pancreatic pseudocysts using the HANAROSTEN® HOT Plumber™ with Z-EUSIT™. | HANAROSTEN® HOT Plumber™ with Z-EUSIT™ An electrocautery-enhanced lumen-apposing metal stent designed for the drainage of pancreatic pseudocysts. The stent is delivered using a system that allows for single-step deployment without the need for guidewire exchanges or tract dilation. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Clinical Success | Reduction of pancreatic pseudocyst size by at least 50% with improvement in associated symptoms. | Within 30 or 60 days after stent placement |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Technical Success - Stent Placement | Successful deployment of the stent at the intended site. | During procedure |
Technical Success - Stent Removal | Successful removal of the stent after pseudocyst resolution, confirmed by endoscopic confirmation of complete stent removal without residual fragments. | Within 30 or 60 days after placement |
Stent Retention | Retention of the stent in the intended location without migration until removal. | Within 30 or 60 days after placement |
Lumen Patency | Maintenance of an open lumen allowing fluid drainage until stent removal. | Within 30 or 60 days after placement |
Procedure Duration | Time from initial needle puncture to full deployment of the stent. | During procedure |
Adverse Events | Incidence of complications such as bleeding, infection, perforation, stent migration, tissue injury, or other adverse events. | From procedure day until one month after stent removal |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Must be 18 years or older
- Diagnosed with pancreatic or peripancreatic pseudocyst or walled-off necrosis (with less than 30% solid components)
- Eligible for endoscopic ultrasound-guided drainage
- Able to provide informed consent and comply with study procedures
- Younger than 18 years old
- Pseudocysts with the following characteristics:
- Immature pseudocyst
- Cystic neoplasm
- Pseudoaneurysm
- Multiple pseudocysts requiring drainage
- Uncontrolled coagulation disorders:
- INR > 1.5
- Platelet count < 50,000/mm³
- Other bleeding disorders
- Ineligibility for EUS-guided drainage due to anatomical or technical reasons
- History of anaphylactic reaction to stent materials
- Pregnant or potentially pregnant women
- Current participation in another clinical trial that may affect study outcomes
서울아산병원M.I.Tech Co., Ltd.연구 책임자
Tae Jun Song, MD, 책임연구자, Professor, Asan Medical Center
연구 대표 연락처
연락처: Tae Jun Song, MD, PhD, 82-2-3010-3914, [email protected]
연락처: Yoonchan Lee, MD, 82-2-3010-1397, [email protected]
1 1개국에 임상시험 장소
Seoul
Asan Medical Center, Seoul, Seoul, 05505, South Korea
Tae Jun Song, MD, PhD, 연락처, 82-2-3010-3914, [email protected]
Yoonchan Lee, MD, 연락처, 82-2-3010-1397, [email protected]
Dongwook Oh, MD, PhD, 책임연구자
모집중