ColonoscopyNCT05213741
Feasibility Trial of Magnetic-assisted Colonoscope Platform
A study testing Autonomous navigation of a magnetic colonoscope in people with Colonoscopy and Colorectal Cancer, run by Taipei Medical University WanFang Hospital.
Trial summary
Colorectal cancer (CRC) screening program can reduce colon cancer-related mortality. Current CRC screening methods include stool occult blood and DNA testing, blood based tests and radiologic tests. Colonoscopy is considered the gold standard to detect colorectal neoplasms. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Colorectal Cancer
- What is being tested?
- Autonomous navigation of a magnetic colonoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20-65 health volunteers without any contraindication
Who cannot join
- Person allergy to polyethylene glycol.
- Phenylkentouria
- Congestive heart failure (NYHA grade 3)
- Renal function impairment.
- Difficulty in swallowing, GI perforation, GI bleeding, toxic enterocolitis, toxic colitis, megacolon, diverticulitis, peritonitis
- Body weight less than 20kg
Show all 17Show fewer
- Wrist more than 120cm
- Gastrointestinal tract obstruction
- Pregnant woman.
- Person with electrical medical implantation such as pacemaker, cochlear implant or other medical devices.
- Person implanted with metal medical device such as metal implantation, metallic stent, metallic denture, metallic valve, metallic joint, metallic joint or plate.
- Person with history of abdominal surgery.
- Person with cancer.
- Person with bleeding tendency
- Person with asthma
- History of cardiac infraction, pulmonary embolism, stroke in recent 6 months
- Heart failure with NYHA grades 4
Trial locations and contacts
No sites are listed yet.
About this study
Colorectal cancer (CRC) screening program can reduce colon cancer-related mortality. Current CRC screening methods include stool occult blood and DNA testing, blood based tests and radiologic tests. Colonoscopy is considered the gold standard to detect colorectal neoplasms. Previous studies have estimated that cancer mortality to be 68% to 88% lower among persons who undergo screening colonoscopy than among those who do not. However, colonoscopy is an invasive examination, and 10% to 20% of patients fail to tolerate the procedure; therefore, greatly reduces the success rate of completion of colon examination.
External controllability of capsule endoscope by means of an applied magnetic field is a possible solution to the maneuvering problem. However, there is no effective system with straight forward clinical applicability till now. This is ascribable to a lack of reliable magnetic instrumentation suitable for such a purpose. We have reported that magnetic field navigator (MFN) can effectively control the locomotion of capsule endoscope. We have demonstrated the feasibility and safety of magnetic-assisted capsule endoscope for the examination of upper gastrointestinal tract. In this study, we develop a magnetic-assisted capsule colonoscope by combination of the integrated circuit complementary metal-oxide-semiconductor imaging sensor, light-emitting diode, and magnetic control technology. This magnetic-assisted capsule colonoscope operation system includes a MFN Platform, high-end hand-controlled joystick, combined circuit component, control interface and software. This magnetic-assisted capsule colonoscope operation system creates a friendly operating environment for the operators, and may establishe a novel screening system for the colon.
Read the detailed description
- Preparation before examination: All subjects must take bowel cleansing drugs as instructed before magnetically controlled colonoscopy After starting to drink laxatives, subjects should continue their daily activities .
- Magnetically Controlled Colonoscopy procedure: No anesthesia will be used during the magnetically controlled colonoscopy in this experiment. The subjects lie down on the magnetic control colonoscopy platform. After the magnetically controlled colonoscopy enters the rectum from the subject's anus, the external magnetron is used to assist and guide the pre-colonoscopy after the magnetically controlled colonoscopy enters the rectum from the subject's anus, and the external magnetron is used to assist and guide the colonoscopy go ahead. During the inspection process, the physician monitors the operation of the magnetically controlled colonoscope throughout the process, and the physician can adjust the movement of the colonoscope when necessary. Whole colorectal examination is defined as the colonoscope must be inserted into the ileocecal region, and the cecum must be photographed.
- Pain assessment during examination: During the colonoscopy, the researchers will conduct a questionnaire to the patients to assess the pain.. The evaluation method is based on the Verbal Scale to evaluate the maximum discomfort, from 0 to 10 points; ; Among them, 0 points are painless, 10 points are the most severe. If the patient's pain assessment score is greater than 5 and the patient cannot tolerate colonoscopy, the examination will be terminated. If there are difficulties during the examination, and the magnetic-controlled colonoscopy cannot complete the examination within 1 hours, the examination shall be terminated.
- After the colonoscopy is completed, the researcher conducts an overall pain assessment to the subjects by means of a questionnaire. On the day after the colonoscopy, the researcher asked the subjects whether they would like to accept the next colonoscopy follow-up examination by means of a questionnaire.
- After the magnetic-controlled colonoscopy, the images and time recorded by the colonoscopy will be interpreted by computer-captured images, and the completion rate of the magnetic-controlled colonoscopy will be analyzed.
- Conditions
- Colonoscopy, Colorectal Cancer
- Being tested
- Autonomous navigation of a magnetic colonoscope
- Keywords
- Colonoscopy, Magnetic-assisted
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomous navigation of a magnetic colonoscopeDevice
The proposed magnetic-assisted colonoscope system consists of an megnetic field nevigator, magnetic-assisted colonoscope, and image receiving decoder. All participants will receive the magnetic-assisted colonoscopic examination by using this proposed magnetic-assisted colonoscope system
| Study group | Role | What they receive |
|---|---|---|
| Magnetic-assisted colonoscopy group | Experimental | Participants in this group will recieve magnetic-assisted colonoscopic examination Receives: Device: Autonomous navigation of a magnetic colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of magnetic-assisted colonoscope system
The completion rate of colonoscopic examination by using the magnetic-assisted colonoscope system
Measured: The end of colonoscopic examination
Safety of magnetic-assisted colonoscope system
The complication rate of colonoscopic examination by using the magnetic-assisted
Measured: The end of colonoscopic examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study startMay 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Principal investigator, Fat-Moon Suk, Taipei Medical University WanFang Hospital
- Investigators
- FAT-MOON SUK, M.D., Principal investigator, Taipei Medical University Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213741
- Sponsor's protocol ID
- N202004113
- Status last verified
- Apr 2023
- First submitted
- 27 Jan 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lien GS, Liu CW, Jiang JA, Chuang CL, Teng MT. Magnetic control system targeted for capsule endoscopic operations in the stomach--design, fabrication, and in vitro and ex vivo evaluations. IEEE Trans Biomed Eng. 2012 Jul;59(7):2068-79. doi: 10.1109/TBME.2012.2198061. Epub 2012 May 7.
PubMed 22581127Yang CS, Suk FM, Chen CN, Chuang CL, Jiang JA, Liu CW, Lien GS. Colonoscopy with magnetic control system to navigate the forepart of colonoscope shortens the cecal intubation time. Surg Endosc. 2014 Aug;28(8):2480-3. doi: 10.1007/s00464-014-3460-7. Epub 2014 Mar 20.
PubMed 24648105Huang HE, Yen SY, Chu CF, Suk FM, Lien GS, Liu CW. Autonomous navigation of a magnetic colonoscope using force sensing and a heuristic search algorithm. Sci Rep. 2021 Aug 13;11(1):16491. doi: 10.1038/s41598-021-95760-7.
PubMed 34389760Lien GS, Wu MS, Chen CN, Liu CW, Suk FM. Feasibility and safety of a novel magnetic-assisted capsule endoscope system in a preliminary examination for upper gastrointestinal tract. Surg Endosc. 2018 Apr;32(4):1937-1944. doi: 10.1007/s00464-017-5887-0. Epub 2017 Oct 25.
PubMed 29071416Yen SY, Huang HE, Lien GS, Liu CW, Chu CF, Huang WM, Suk FM. Automatic lumen detection and magnetic alignment control for magnetic-assisted capsule colonoscope system optimization. Sci Rep. 2021 Mar 19;11(1):6460. doi: 10.1038/s41598-021-86101-9.
PubMed 33742067
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Magnetic-assisted Colonoscope Platform
- ClinicalTrials.gov ID
- NCT05213741
- Acronym / sponsor ID
- N202004113
- Conditions
- Colonoscopy, Colorectal Cancer
- Keywords
- Colonoscopy, Magnetic-assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer (CRC) screening program can reduce colon cancer-related mortality. Current CRC screening methods include stool occult blood and DNA testing, blood based tests and radiologic tests. Colonoscopy is considered the gold standard to detect colorectal neoplasms. Previous studies have estimated that cancer mortality to be 68% to 88% lower among persons who undergo screening colonoscopy than among those who do not. However, colonoscopy is an invasive examination, and 10% to 20% of patients fail to tolerate the procedure; therefore, greatly reduces the success rate of completion of colon examination.
External controllability of capsule endoscope by means of an applied magnetic field is a possible solution to the maneuvering problem. However, there is no effective system with straight forward clinical applicability till now. This is ascribable to a lack of reliable magnetic instrumentation suitable for such a purpose. We have reported that magnetic field navigator (MFN) can effectively control the locomotion of capsule endoscope. We have demonstrated the feasibility and safety of magnetic-assisted capsule endoscope for the examination of upper gastrointestinal tract. In this study, we develop a magnetic-assisted capsule colonoscope by combination of the integrated circuit complementary metal-oxide-semiconductor imaging sensor, light-emitting diode, and magnetic control technology. This magnetic-assisted capsule colonoscope operation system includes a MFN Platform, high-end hand-controlled joystick, combined circuit component, control interface and software. This magnetic-assisted capsule colonoscope operation system creates a friendly operating environment for the operators, and may establishe a novel screening system for the colon.
Detailed description
- Preparation before examination: All subjects must take bowel cleansing drugs as instructed before magnetically controlled colonoscopy After starting to drink laxatives, subjects should continue their daily activities .
- Magnetically Controlled Colonoscopy procedure: No anesthesia will be used during the magnetically controlled colonoscopy in this experiment. The subjects lie down on the magnetic control colonoscopy platform. After the magnetically controlled colonoscopy enters the rectum from the subject's anus, the external magnetron is used to assist and guide the pre-colonoscopy after the magnetically controlled colonoscopy enters the rectum from the subject's anus, and the external magnetron is used to assist and guide the colonoscopy go ahead. During the inspection process, the physician monitors the operation of the magnetically controlled colonoscope throughout the process, and the physician can adjust the movement of the colonoscope when necessary. Whole colorectal examination is defined as the colonoscope must be inserted into the ileocecal region, and the cecum must be photographed.
- Pain assessment during examination: During the colonoscopy, the researchers will conduct a questionnaire to the patients to assess the pain.. The evaluation method is based on the Verbal Scale to evaluate the maximum discomfort, from 0 to 10 points; ; Among them, 0 points are painless, 10 points are the most severe. If the patient's pain assessment score is greater than 5 and the patient cannot tolerate colonoscopy, the examination will be terminated. If there are difficulties during the examination, and the magnetic-controlled colonoscopy cannot complete the examination within 1 hours, the examination shall be terminated.
- After the colonoscopy is completed, the researcher conducts an overall pain assessment to the subjects by means of a questionnaire. On the day after the colonoscopy, the researcher asked the subjects whether they would like to accept the next colonoscopy follow-up examination by means of a questionnaire.
- After the magnetic-controlled colonoscopy, the images and time recorded by the colonoscopy will be interpreted by computer-captured images, and the completion rate of the magnetic-controlled colonoscopy will be analyzed.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic-assisted colonoscopy group | Experimental | Device: Autonomous navigation of a magnetic colonoscopeParticipants in this group will recieve magnetic-assisted colonoscopic examination |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 20-65 health volunteers without any contraindication
Key exclusion criteria (17 listed)
- Person allergy to polyethylene glycol.
- Phenylkentouria
- Congestive heart failure (NYHA grade 3)
- Renal function impairment.
- Difficulty in swallowing, GI perforation, GI bleeding, toxic enterocolitis, toxic colitis, megacolon, diverticulitis, peritonitis
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 |
|---|---|---|
| Autonomous navigation of a magnetic colonoscopeThe proposed magnetic-assisted colonoscope system consists of an megnetic field nevigator, magnetic-assisted colonoscope, and image receiving decoder. All participants will receive the magnetic-assisted colonoscopic examination by using this proposed magnetic-assisted colonoscope system | Device | Magnetic-assisted colonoscopy group |
Primary outcome
Feasibility of magnetic-assisted colonoscope system
Time frame: The end of colonoscopic examination
The completion rate of colonoscopic examination by using the magnetic-assisted colonoscope system
Safety of magnetic-assisted colonoscope system
Time frame: The end of colonoscopic examination
The complication rate of colonoscopic examination by using the magnetic-assisted
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Background: PubMed 22581127Lien GS, Liu CW, Jiang JA, Chuang CL, Teng MT. Magnetic control system targeted for capsule endoscopic operations in the stomach--design, fabrication, and in vitro and ex vivo evaluations. IEEE Trans Biomed Eng. 2012 Jul;59(7):2068-79. doi: 10.1109/TBME.2012.2198061. Epub 2012 May 7.
- Background: PubMed 24648105Yang CS, Suk FM, Chen CN, Chuang CL, Jiang JA, Liu CW, Lien GS. Colonoscopy with magnetic control system to navigate the forepart of colonoscope shortens the cecal intubation time. Surg Endosc. 2014 Aug;28(8):2480-3. doi: 10.1007/s00464-014-3460-7. Epub 2014 Mar 20.
- Background: PubMed 34389760Huang HE, Yen SY, Chu CF, Suk FM, Lien GS, Liu CW. Autonomous navigation of a magnetic colonoscope using force sensing and a heuristic search algorithm. Sci Rep. 2021 Aug 13;11(1):16491. doi: 10.1038/s41598-021-95760-7.
- Background: PubMed 29071416Lien GS, Wu MS, Chen CN, Liu CW, Suk FM. Feasibility and safety of a novel magnetic-assisted capsule endoscope system in a preliminary examination for upper gastrointestinal tract. Surg Endosc. 2018 Apr;32(4):1937-1944. doi: 10.1007/s00464-017-5887-0. Epub 2017 Oct 25.
- Background: PubMed 33742067Yen SY, Huang HE, Lien GS, Liu CW, Chu CF, Huang WM, Suk FM. Automatic lumen detection and magnetic alignment control for magnetic-assisted capsule colonoscope system optimization. Sci Rep. 2021 Mar 19;11(1):6460. doi: 10.1038/s41598-021-86101-9.
- 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.
FAT-MOON SUK, M.D. principal investigator
Taipei Medical University Wan Fang Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Autonomous navigation of a magnetic colonoscope in people with Colonoscopy and Colorectal Cancer, run by Taipei Medical University WanFang Hospital.
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 1 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FAT-MOON SUK, M.D. (+886229307930 ext. 1541, sukfm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of magnetic-assisted colonoscope system (time frame: The end of colonoscopic examination). The study lists 2 primary outcomes in all. 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 NCT05213741, which also lists 5 linked publications.
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 20 Apr 2023.