Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Expulsion Duration
研究概览
简要总结
Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy.
详细描述
This study aims to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data using a new medical device. This study is specifically for patients with dyssynergia before, during, and after biofeedback therapy. The balloon-like Fecobionics device (10 cm long and 1 cm in diameter) will be inserted into the participant's rectum and will record data before and during the expulsion of the device. The participant will be asked to do different motions like cough, squeeze, or push during the procedure. The novel data obtained in this study may help the investigators to identify the patients who will benefit or not benefit from biofeedback therapy before the therapy is done. This will determine the effectiveness of treatments for anorectal disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must provide written informed consent.
- •Age between 21-75 years.
- •Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.
排除标准
- •Female who is pregnant or lactating.
- •Prior abdominal or anorectal surgery or bowel resection.
- •Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
- •Confirmed or suspected COVID-19 infection.
- •Severe cardiovascular disease.
- •Subjects not willing to consent and undergo the specified tests in this study.
- •Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.
结局指标
主要结局
Expulsion Duration
时间窗: 1.5 year
The time it takes to defecate Fecobionics
Pressure Difference between front and rear ends of Fecobionics
时间窗: 1.5 year
A measure of anal sphincter pressure, the driving rectal pressure, and the difference between these two pressures. This is the key to the determination of defecation phases.
次要结局
- Mechanical Tension of Fecobionics(1.5 year)
- Expulsion Velocity(1.5 year)
- Cross-sectional area(1.5 year)
- Anorectal angle(1.5 year)
研究者
Hans Gregersen, PhD
CEO
The California Medical Innovations Institute, Inc.