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临床试验/NCT05833789
NCT05833789已完成不适用

Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年10月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes

研究概览

简要总结

In this study, the investigators will evaluate the ability of the Magnetic Flexible Endoscope (MFE) to travel through the human colon. The MFE is a device made of ultra-flexible tubing that contains a camera, light, and magnet at the tip. The tip of the tube is about the size of a penny. The magnet inside the tip allows the MFE to be moved through the colon by a second magnet attached to a robotic arm that is outside the body. The objective of this feasibility study is to determine navigation of the colon and tolerability of the Magnetic Flexible Endoscope (MFE) traveling in the human colon.

详细描述

The clinical practice at Vanderbilt University Medical Center (VUMC) is to perform the screening colonoscopic exam while the patient is sedated (Monitored Anesthesia Care administered by the VUMC out-of-OR Anesthesia team) with a legacy colonoscope (Olympus CF/PCF-H190L; Olympus America, Center Valley, PA, USA) to evaluate the patient's colon (via the rectum passed trans-anally with the intent of reaching the cecum). After the screening examination with the legacy colonoscope has been completed and the legacy colonoscope is removed from the patient, the sedation for the patient is stopped as per the standard of care. The patient will be monitored as per VUMC standard of care post-sedation monitoring protocol in the procedure room (post-sedation recovery phase). While the patient is in the post-sedation recovery phase in the procedure room, the MFE will be inserted trans-anally into the rectum and traverse the colon with the intent on reaching the cecum. No additional sedation is administered. After the cecum is visualized, the MFE will be removed from the patient. The patient will continue to be monitored as per VUMC standard of care post-procedure monitoring protocol in the procedure room. Once VUMC standard of care discharge parameters have been met, the patient will be discharged from the procedure area/VUMC as per standard of care. The investigators plan to enroll 5 healthy patients who are already scheduled to undergo their standard of care colonoscopic exam for age-appropriate colorectal cancer screening. The endpoints of the study are navigation of the colon, mucosal visibility, tolerability of the MFE traveling in the human colon, and endoscopist assessment.

研究设计

研究类型
Interventional
分配方式
Na
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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female, 18 to 70 years of age.
  • •Able to provide written informed consent.
  • •ASA class < 3
  • •No significant medical problems
  • •Abdominal circumference < 96 cm

排除标准

  • •Patients who do not meet inclusion criteria
  • •Patients who are unable or unwilling to provide informed consent
  • •Magnetic implants and wearable devices (such as insulin pumps)
  • •Patients who are pregnant. As part of routine pre-operative care, all patients with uterus who are of childbearing potential will undergo either urine or blood pregnancy testing
  • •Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer
  • •Symptoms consistent with coronavirus (COVID-19) --- pyrexia, new persistent cough or anosmia --- or a positive coronavirus (COVID-19) PCR swab result
  • •Previous failed colonoscopy
  • •Colonic resection
  • •Severe diverticulosis
  • •Known or suspected colonic stricture
  • •Previous radiation therapy to the abdomen or pelvis
  • •Any active inflammatory bowel condition (e.g. active IBD or diverticulitis)
  • •Known or suspected bowel obstruction
  • •Presence of ascites
  • •Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) within the last 7 days
  • •Known coagulation disorder (INR ≥ 1.5 or platelets < 150 x 10^9)
  • •Known to have phenylketonuria or G6PD deficiency
  • •Abdominal surgery within the last 6 months
  • •Drug or alcohol abuse

研究组 & 干预措施

Colonoscopy for colorectal cancer screening

Experimental

All patients in this group will have their colonoscopy for colorectal cancer screening completed with a legacy colonoscope followed by colonoscopy with the Magnetic Flexible Endoscope (MFE).

干预措施: Magnetic Flexible Endoscope (MFE) (Device)

结局指标

主要结局

MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes

时间窗: Day 1

Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes

次要结局

  • MFE Tolerability by Post-procedure Interview(Day 1)
  • Endoscopist Experience by NASA Task Load Index (TLX)(Day 1)
  • Colon Mucosal Visibility(Day 1)

研究者

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

Keith Obstein

Professor of Medicine

Vanderbilt University Medical Center

研究点 (1)

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