N/A N=5 Device Feasibility

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

Colonoscopy

Bottom Line

View on ClinicalTrials.gov: NCT05833789 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes — 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Magnetic Flexible Endoscope (MFE) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University Medical Center
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes	—	—
SECONDARY MFE Tolerability by Post-procedure Interview	—	—
SECONDARY Endoscopist Experience by NASA Task Load Index (TLX)	31; 44; 28; 47; 36; 40	—
SECONDARY Colon Mucosal Visibility	3	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05833789). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.