An interventional study of Autonomous navigation of a magnetic colonoscope in Colonoscopy and Colorectal Cancer, sponsored by Taipei Medical University WanFang Hospital. Status unknown. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Taipei Medical University WanFang Hospital · Not applicable, Interventional, and Device feasibility
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 10 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Taipei Medical University WanFang Hospital is the lead sponsor of 196 studies on the registry; 19 are open to participants now.
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Aged 20-65 health volunteers without any contraindication
Exclusion Criteria:
Participants in this group will recieve magnetic-assisted colonoscopic examination
Device: Autonomous navigation of a magnetic colonoscope
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
Feasibility of magnetic-assisted colonoscope system
The completion rate of colonoscopic examination by using the magnetic-assisted colonoscope system
Time frame: The end of colonoscopic examination
Safety of magnetic-assisted colonoscope system
The complication rate of colonoscopic examination by using the magnetic-assisted
Time frame: The end of colonoscopic examination
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Taipei Medical University WanFang Hospital