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

NCT05833789 | Completed Results FDA Device

• 2 other identifiers: MFE_2222935R01EB018992-07
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy

Keywords

Colonoscopy; Colon; Robotic; Magnetic; Endoscopy

Outcome Measures

Primary Outcomes (1)

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

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

  Day 1

Secondary Outcomes (3)

• MFE Tolerability by Post-procedure Interview

  Day 1

• Endoscopist Experience by NASA Task Load Index (TLX)

  Day 1

• Colon Mucosal Visibility

  Day 1

Study Arms (1)

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).

Device: Magnetic Flexible Endoscope (MFE)

Interventions

Magnetic Flexible Endoscope (MFE) DEVICE

After colonoscopy has been completed with the legacy colonoscope, the MFE will be introduced into the colon and traverse from the rectum to the cecum.

Colonoscopy for colorectal cancer screening

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Obstein KL, Landewee CA, Martin J, Calo S, Norton J, Wai Kow J, Scaglioni B, Valdastri P. The Magnetic Flexible Endoscope: Phase 1 First-in-Human Clinical Trial. Am J Gastroenterol. 2025 Jun 10:10.14309/ajg.0000000000003584. doi: 10.14309/ajg.0000000000003584. Online ahead of print.

  PMID: 40493042 DERIVED

Results Point of Contact

• Title: Michael McGill
• Organization: Vanderbilt University Medical Center

michael.g.mcgill@vumc.org

615-322-0128

Study Officials

• Keith L Obstein

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 27, 2023
• Study Start: October 12, 2023
• Primary Completion: October 13, 2023
• Study Completion: October 13, 2023
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)