jRCT2052260049招募中不适用
A First-in-Human, Investigator-Initiated Trial to Evaluate the Safety and Efficacy of Superior Mesenteric Artery Denervation (SMADN) in Refractory Chronic Constipation
未提供0 个研究点目标入组 12 人开始时间: 待定
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1)Subjects aged 18 years or older at the time of obtaining informed consent.
- •(2)Subjects who have provided written informed consent.
- •(3)Subjects who meet the diagnostic criteria for chronic constipation according to the Rome IV criteria.
- •(4) Subjects who have fewer than three spontaneous bowel movements (SBMs) per week despite adequate conventional treatment, and who are judged to be refractory to treatment by the principal investigator or sub-investigator.
- •(5) Subjects diagnosed with slow-transit constipation based on the Sitzmarks(R) 3-day method
排除标准
- •(1)Subjects who meet the Rome IV criteria for irritable bowel syndrome with diarrhea (IBS-D).
- •(2)Subjects with a history of or current inflammatory bowel disease.
- •(3)Subjects with active infectious enteritis at the time of enrollment.
- •(4)Subjects with a history of or current stoma.
- •(5)Subjects with a history of or current functional defecation disorders among functional constipation.
- •(6)Subjects with a history of or current organic defecatory disorder among non-obstructive organic constipation
- •(7) Subjects with drug-induced constipation in whom the causative drug has been identified and for whom improvement is expected through discontinuation or dose reduction of the causative drug, or administration of an antagonist.
- •(8)Subjects with a history of or current stenotic organic constipation.
- •(9)Subjects with a history of or current Hirschsprung's disease or allied disorders.
- •(10)Subjects with hypersensitivity to barium sulfate or any component of Sitzmarks(R).
- •(11)Subjects with allergy to rice bran used in defecography.
- •(12)Subjects with anatomical variations or morphological abnormalities of the superior mesenteric artery (SMA) (e.g., celiacomesenteric type, calcification involving >=50% of the vessel circumference, stenosis, dissection, or aneurysmal dilation (<=70% or >=150% of the normal vessel diameter).
- •(13)Subjects who are unable to discontinue anticoagulant therapy before and after superior mesenteric artery denervation (SMADN) treatment.
- •(14)Subjects with a history of allergy to iodinated contrast agents.
- •(15)Subjects with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m
- •(16)Subjects diagnosed with an active infection.
- •(17)Subjects diagnosed with an uncontrolled bleeding tendency.
- •(18)Subjects who are pregnant, planning to become pregnant during the study period, or unwilling to use contraception during the study period.
- •(19)Subjects deemed inappropriate for participationby the principal investigator or sub-investigator.
研究者
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