Colonoscopic Investigation of the Correlation Between Bowel Wall Inflammation and Luminal Temperature Rise in IBD
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ability of thermal probe to collect temperature measurements from colonic mucosa
研究概览
简要总结
The goal of this clinical trial is to use a modified thermal probe to measure temperature rise in the colonic mucosa of participants with inflammatory bowel disease, Crohn's disease, and/or ulcerative colitis. The main question it aims to answer is:
Is the thermal probe an effective device to use to detect temperature rise in the colonic mucosa?
During the participant's standard of care colonoscopy, the thermal probe will be inserted into the colonoscope. The thermal probe is connected to a temperature transmitter that collects and saves the temperature of the colon in real time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 否
入选标准
- •Participants 18 years or older
- •Participants undergoing elective colonoscopy
- •Participants capable of following requirements
- •Participants capable of providing informed consent
- •Participants with a diagnosis of IBD, Crohn's disease, and/or ulcerative colitis or participants undergoing colorectal cancer screening
排除标准
- •Participants contraindicated for colonoscopy, including experiencing acute events within the last 6 weeks prior to the colonoscopy (i.e. subjects suffering from a myocardial infarction (heart attack), diagnosis of peritonitis (the inflammation of the membrane lining of the abdominal wall), diagnosis of hemodynamic instability (shock), surgery involving colonic anastomosis (reconnection of the colon), and/or bowel injury (from trauma or surgery)
- •Participants who are pregnant
研究组 & 干预措施
IBD, Crohn's Disease, and/or UC
10 adult participants currently diagnosed with inflammatory bowel disease (IBD), Crohn's disease, and/or ulcerative colitis (UC) will be enrolled at MGH
干预措施: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa (Device)
Undergoing Colorectal Screening
10 adult subjects undergoing colorectal cancer screening will be enrolled at MGH
干预措施: Feasibility of using a thermal probe to measure temperature rise in colonic mucosa (Device)
结局指标
主要结局
Ability of thermal probe to collect temperature measurements from colonic mucosa
时间窗: Thermal measurements are collected during the study procedure and analyzed within one year of collection.
次要结局
未报告次要终点
研究者
Guillermo Tearney
Principal Investigator
Massachusetts General Hospital