ColonoscopyNCT05833789
Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)
A study testing Magnetic Flexible Endoscope (MFE) in people with Colonoscopy, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Magnetic Flexible Endoscope (MFE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 13 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the detailed description
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.
- Conditions
- Colonoscopy
- Being tested
- Magnetic Flexible Endoscope (MFE)
- Keywords
- Colonoscopy, Colon, Robotic, Magnetic, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Magnetic Flexible Endoscope (MFE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (3)
MFE Tolerability by Post-procedure Interview
Number of reported non-tolerability events, including events associated with the product's administration affecting the ability or desire of the patient to adhere to the intensity of therapy. Tolerability was assessed through qualitative interview post procedure.
Measured: Day 1
Endoscopist Experience by NASA Task Load Index (TLX)
The NASA Task Load Index (TLX) is a validated assessment instrument (Ames Research Center, Moffett Field, CA, USA) to assess perceived workload based on a multidimensional construct of six sub-scales: mental demand, physical demand, temporal demand, performance, effort, and frustration level. The sub-scales range from 0 (very low) to 100 (very high); the exception is the sub-scale of performance, where 0 is perfect and 100 is failure.
Measured: Day 1
Colon Mucosal Visibility
Colon mucosal visibility scale is an operator assessed cumulative score utilizing the colon visualization index which has a score range of 0-4, where 0 is poor and 4 is excellent.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start12 Oct 2023
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Keith Obstein, Vanderbilt University Medical Center
- Investigators
- Keith L Obstein, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833789
- Sponsor's protocol ID
- MFE_222293
- Other IDs
- 5R01EB018992-07
- Status last verified
- Dec 2024
- First submitted
- 12 Apr 2023
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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. 2026 Apr 1;121(4):871-880. doi: 10.14309/ajg.0000000000003584. Epub 2025 Jun 10.
PubMed 40493042
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)
- ClinicalTrials.gov ID
- NCT05833789
- Acronym / sponsor ID
- MFE_222293
- Conditions
- Colonoscopy
- Keywords
- Colonoscopy, Colon, Robotic, Magnetic, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy for colorectal cancer screening | Experimental | Device: Magnetic Flexible Endoscope (MFE)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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Flexible Endoscope (MFE)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. | Device | Colonoscopy for colorectal cancer screening |
Primary outcome
MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes
Time frame: Day 1
Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes
3 secondary outcomes
MFE Tolerability by Post-procedure Interview
Time frame: Day 1
Endoscopist Experience by NASA Task Load Index (TLX)
Time frame: Day 1
Colon Mucosal Visibility
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40493042Obstein 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. 2026 Apr 1;121(4):871-880. doi: 10.14309/ajg.0000000000003584. Epub 2025 Jun 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith L Obstein principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Flexible Endoscope (MFE) in people with Colonoscopy, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.