跳至主要内容
临床试验/NCT06493032
NCT06493032招募中不适用

The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM

Indiana University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月7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
入组人数
20
试验地点
1
主要终点
Body Surface Gastric Mapping Rhythm IndexTM (GA-RI)

研究概览

简要总结

The purpose of this study is to investigate whether or not the investigators can utilize Body Surface Gastric Mapping to determine who would best benefit to receive G-POEM procedure and how Body Surface Gastric Mapping can be utilized with patients who have gastroparesis symptoms. the investigators may also be able to find more ways how Body Surface Gastric Mapping testing can benefit patients with gastroparesis and/or G-POEM procedure.

详细描述

The aim of this protocol is to build on the investigators currently approved study to evaluate the outcomes and predictors of success of Gastric peroral endoscopic myotomy (G-POEM). The investigators plan to incorporate BSGM in determining the treatment success after G-POEM in patients with refractory gastroparesis and potentially identify a phenotype of gastroparesis patients who may respond more favorably to G-POEM based on their baseline BSGM profile. The currently approved G-POEM study (IRB #1708840627 and ClinicalTrials.gov ID NCT04434781) at our center tracks patients' symptoms and quality of life at baseline and post G-POEM. the investigators plan to supplement the existing study by adding BSGM variables. Although the investigators have specific outcomes identified, the investigators would like to stress that this is a pilot study that will serve to identify patterns and trends that could be studied further in the future using larger cohorts of patients.

The investigators' primary objective is to evaluate the safety and feasibility BSGM in refractory gastroparesis patients undergoing G-POEM.

the investigators will also investigate whether changes in BSGM measures correlate with changes in symptoms and quality of life.

Additionally, the investigators' aim to compare the diagnostic performance of BSGM, and gastric emptying scans as depicted on scintigraphy.

The investigators' primary aim is to assess the feasibility and safety of in gastroparesis patients undergoing G-POEM. Clinical success is defined as improvement in GCSI by 1 point or more compared to baseline.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients clinically eligible for G-Poem at our center.

排除标准

  • • Pregnant or breast-feeding
  • Patients with gastroparesis due to spinal cord injuries due to difficulties in conducting the BSGM. Of note, we rarely see gastroparesis in this context.
  • Inability to perform BSGM: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.
  • Patients with abdominal drains or tubes

研究组 & 干预措施

Body Surface Gastric Mapping

Experimental

干预措施: Gastric Alimetry System (Device)

结局指标

主要结局

Body Surface Gastric Mapping Rhythm IndexTM (GA-RI)

时间窗: Baseline, 3 months,6 months, up to 5 hours.

A measure of the concentration of amplitude in the gastric frequency band over time (between 0 and 1), which characterizes the rhythmic stability of the recorded gastric activity; also adjusted for BMI.

Principal Gastric Frequency

时间窗: Baseline, 3 months,6 months, up to 5 hours.

Characterizes the frequency associated with stable, persistent gastric activity as defined by GA-R

BMI-Adjusted Amplitude (μV)

时间窗: Baseline, 3 months,6 months, up to 5 hours.

characterizes the strength of the recorded gastric activity as an average of the whole-test amplitude, adjusted for BMI

SF-36

时间窗: Baseline, 3 months,6 months, up to 5 hours.

a set of generic, coherent, and easily administered quality-of-life measures

Fed: Fasted Amplitude Ratio (ff-AR)

时间窗: Baseline, 3 months,6 months, up to 5 hours.

characterizes the responsiveness to a meal stimulus, which is calculated as a ratio of the maximal 1-h average postprandial amplitude to the amplitude in the preprandial period.

次要结局

  • Body surface gastric mapping (BSMG)(Baseline, 3 months,6 months, up to 5 hours.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Al-Haddad

Principal Investigator

Indiana University

研究点 (1)

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