NCT07540312招募中不适用
A Prospective Interventional Trial With a Non-invasive Variable Compression System (VCS) to Determine the Efficacy in Patients With Moderate to Severe Irritable Bowel Syndrome (IBS)
PGP Health3 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Incidence of intolerable treatment-related adverse events (AEs)
研究概览
简要总结
This prospective, interventional trial is intended to determine the safety and effectiveness of the Variable Compression System (VCS) device for Irritable Bowel Syndrome (IBS). This pilot study will enroll 20 subjects who will be required to wear the VCS device for a minimum of 6 hours a day and follow up at 21 days, 8 weeks, and 6 months post-device administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the trial as prescribed.
- •Subjects with a weight of ≥50 kg and a body mass index between 18 and 40 kg/m
- •Diagnosed with IBS(C)-constipation, IBS(D)-diarrhea, or IBS(M)-mixed patients' diagnosis according to Rome Criteria (moderate to severe).
排除标准
- •Allergy to the investigational device or any components or clinically significant allergies (excluding mild seasonal allergies), in the opinion of the investigator.
- •Clinically relevant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or psychiatric disorders making implementation of the protocol or interpretation of the trial results difficult, or that would put the participant at risk by participating in the trial in the opinion of the Investigator.
- •Hospital admission or major surgery within 30 days prior to screening.
- •Pregnant, or positive urine pregnancy test.
- •Participation in any other investigational drug trial within 30 days prior to screening.
- •Participant with substance use disorder (SUD) and/or alcohol use disorder (AUD).
- •Participant who has other conditions that may affect compliance in the opinion of the investigator, or who are unable to participate in the trial on his/her own.
- •Participant with end stage organ disease.
研究组 & 干预措施
Pilot Cohort
Experimental
Wear VCS device for 6+ hours per day
干预措施: Variable Compression System (Device)
结局指标
主要结局
Incidence of intolerable treatment-related adverse events (AEs)
时间窗: 21 days
Incidence, severity, and causal relationship of treatment-emergent AEs (TEAEs)
时间窗: 21 days
次要结局
- Improvement in IBS-related symptoms(21 days)
研究者
研究点 (3)
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