The Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Healthy Volunteers, a Phase 1 Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability
研究概览
简要总结
Photo-bio-stimulation by Low Level Light therapy(LLLT) has demonstrated its clinical use in chemotherapy/radiotherapy oral mucositis.
Unpublished study (Melzer, Ben-Yehuda et al. UEGW 2012) with the Photopill (LLLT) capsule treatment in mice showed a significant beneficial effect on the endoscopic severity of DSS-induced colitis in mice.
Therefore a phase 1 trial is designed to assess the safety and feasibility of the Photopill treatment in healthy volunteers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are generally healthy.
- •Signed informed consent.
排除标准
- •Subjects with any known GI related symptoms complaints or GI diseases.
- •Subjects with cancer or other life threatening diseases or conditions.
- •Subjects with cardiovascular or pulmonary diseases.
- •Pregnant women.
- •Subjects who underwent any colon surgery.
- •Morbid Obesity (BMI > 40).
- •Drug abuse or alcoholism.
- •Bed-ridden patient.
- •Any rectal therapy.
- •Participation in current clinical study or clinical study within 30 days prior to the study.
研究组 & 干预措施
Photopill treatment
Photopill treatment, 2 minutes per cm rectal mucosa (3cm) 10 times
干预措施: Photopill treatment (Device)
结局指标
主要结局
Number of Participants with Adverse Events (Mucosal Aspect at 2nd sigmoidoscopy after 7-14 days) as a Measure of Safety and Tolerability
时间窗: During Study period: day 0-14
次要结局
未报告次要终点
研究者
Hanke Brandse
MD, Phd student, executive investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)