NCT04502732终止不适用
Direct Comparison of Short- And Long-Term Gastric Emptying By Nuclear Scintigraphy and Gastric Emptying Breath Test in Subjects Undergoing Endoscopic Gastric Remodeling For Weight Loss
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change of T1/2
研究概览
简要总结
The purpose of this study is to compare a less invasive breath test against the current standard for assessing gastric (stomach) emptying. The current standard of care is a procedure called Nuclear Scintigraphy of a Solid Meal (NSSM). This study will compare this method to a Gastric Emptying Breath Test (GEBT).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 22-65 years of age at time of enrollment
- •Subjects must already be consented to 17-007934 or 19-001254
- •Subject must be agreeable and compliant with study requirements, including up to three (baseline, 2 month, and 6 month) visits, as well as undergoing GEBT and NSSM testing.
- •If female, must be post-menopausal, surgically sterile, or agree to practice a form of birth control or abstinence during year of study and have negative serum HCG at screening/baseline
- •Must be willing and able to travel, as needed, to the Investigator's office to complete all routine follow-up visits
排除标准
- •Persons presently or soon to be incarcerated
- •Females who are pregnant or suspect they may be pregnant
- •Persons with nicotine and/or alcohol dependence
- •Patients with cognitive impairment that limits their ability to make autonomous decisions
- •Known allergies or sensitivities to study materials (eggs and spirulina)
- •Assessed, by the physician or delegate, that enrollment would not be appropriate
结局指标
主要结局
Change of T1/2
时间窗: Baseline, 2 months, 6 months
The aim of this study is to compare baseline, early post-procedural (2 month), and delayed post-procedural (6 month) T1/2, as assessed by both GEBT and NSSM, in seven adult subjects with obesity who have underwent an EGRWL procedure.
次要结局
未报告次要终点
研究者
Barham K. Abu Dayyeh, M.D.
Principal Investigator
Mayo Clinic
研究点 (1)
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