Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD)

Обзор

In this study, the investigators will test the ability of the Magnetic Flexible Endoscope (MFE) to travel through the colon of people with Inflammatory Bowel Disease (IBD). 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 purpose of this study is to see how the MFE travels through the colon of IBD patients and if it is tolerable.

Подробное описание

Colonoscopy is the gold standard for making the diagnosis, following clinical response, establishing prognosis, and creation of management plans for patients with Inflammatory Bowel Disease (IBD). While colonoscopy is a relatively safe procedure, there are several limitations due to the unintuitive drive mechanism and mechanical design of current conventional colonoscopes. Additionally, for patients with IBD, the procedure is associated with a higher lifetime risk of adverse event due to increased frequency of examination-more than a 6-fold increased risk when compared to their non-IBD counterparts.

For these reasons, our team has developed a novel, highly compliant, Magnetic Flexible Endoscope (MFE) with the functionality of a conventional colonoscope (i.e. camera, therapeutic channel, irrigation, insufflation, illumination, lens cleaning). The MFE is driven by magnetic coupling of the endoscope head that contains an internal permanent magnet and a robotic arm that holds an external permanent magnet. This enables a "front-pull" actuation mechanism to eliminate the need for pushing a semi-rigid insertion tube for advancement. The forward drive mechanism thus prevents buckling of the insertion tube and avoids looping/colon wall stress. This reduces the risk of perforation and pain during the procedure to allow for less (if any) procedural sedation.

The Magnetic Flexible Endoscope (MFE) is a single-use endoscope intended to integrate with other commercially available devices for the visualization of a human colon in order to eliminate the need for passage of the much stiffer, non-intuitive, risk prone standard colonoscope. This study builds on the successful completion of the first-in-human feasibility study that demonstrated safety and tolerability in healthy patients who were already scheduled for their routine standard-of-care screening colonoscopy. In this secondary study, the MFE device will be inserted into the rectum via the anus and navigated through the colon to the cecum, using magnetic manipulation, in patients with stable, non-active, Inflammatory Bowel Disease (IBD) who are due for their IBD/colorectal cancer surveillance/screening colonoscopy exams.

The investigators plan to assess safety and tolerability of MFE navigation in the colon from the rectum to the cecum in patients with stable non-active IBD who are due for their IBD/Colorectal Cancer surveillance/screening colonoscopy exams. This will be a parallel study design in which three of six patients will have standard of care colonoscopy completed with monitored anesthesia care (MAC) first followed by MFE and three of six patients will undergo unsedated MFE first followed by standard of care colonoscopy completed with MAC.

Вмешательства

• Устройство Magnetic Flexible Endoscope (MFE)
  The Magnetic Flexible Endoscope (MFE) is a single-use endoscope intended to integrate with other commercially available devices for visualization of the human colon in order to eliminate the need for passage of the much stiffer, non-intuitive, risk prone standard colonoscope. The MFE will be introduced into the colon and traverse from the rectum to the cecum.

Первичные конечные точки

• Feasibility to intubate the cecum (yes/no) [Срок оценки: Day 1]

Вторичные конечные точки (3)

• Mucosal visibility [Срок оценки: Day 1]
• Patient tolerance [Срок оценки: Day 1]
• Endoscopist experience [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Male or female, 18 to 70 years of age
• Able to provide written informed consent
• American Society of Anesthesiologists (ASA) class < 3
• No significant medical problems
• Abdominal circumference < 96 cm
• Stable, non-flaring inflammatory bowel disease (e.g. Ulcerative Colitis and Crohn's Disease)

Критерии исключения

• 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)
• Females who are pregnant. As part of routine pre-operative care, all females 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) polymerase chain reaction (PCR) swab result
• Previous incomplete or failed colonoscopy
• Colonic resection
• Severe diverticulosis
• Known or suspected colonic stricture
• Previous radiation therapy to the abdomen or pelvis
• Actively flaring inflammatory bowel condition (e.g. active flare of IBD or diverticulitis)
• Known or suspected bowel obstruction
• Presence of ascites
• Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) within the last 3 days
• Known coagulation disorder (INR ≥ 1.5 or platelets < 150 x 109)
• Known to have phenylketonuria or Glucose-6-Phosphate-Dehydrogenase (G6PD) deficiency
• Abdominal surgery within the last 6 months
• Drug or alcohol abuse

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• Vanderbilt University Medical Center — Nashville

Идентификаторы

NCT: NCT06989424 · MFEIBD_241894 · 5R01EB018992-08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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