Feasibility Trial of Magnetic-assisted Colonoscope Platform
Primary Purpose
Colonoscopy, Colorectal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autonomous navigation of a magnetic colonoscope
Sponsored by
About this trial
This is an interventional device feasibility trial for Colonoscopy focused on measuring Colonoscopy, Magnetic-assisted
Eligibility Criteria
Inclusion Criteria:
Aged 20-65 health volunteers without any contraindication
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magnetic-assisted colonoscopy group
Arm Description
Participants in this group will recieve magnetic-assisted colonoscopic examination
Outcomes
Primary Outcome Measures
Feasibility of magnetic-assisted colonoscope system
The completion rate of colonoscopic examination by using the magnetic-assisted colonoscope system
Safety of magnetic-assisted colonoscope system
The complication rate of colonoscopic examination by using the magnetic-assisted
Secondary Outcome Measures
Full Information
NCT ID
NCT05213741
First Posted
January 27, 2022
Last Updated
April 19, 2023
Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT05213741
Brief Title
Feasibility Trial of Magnetic-assisted Colonoscope Platform
Official Title
Feasibility Trial of Magnetic-assisted Colonoscope Platform
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Ministry of Health and Welfare, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Colorectal Cancer
Keywords
Colonoscopy, Magnetic-assisted
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnetic-assisted colonoscopy group
Arm Type
Experimental
Arm Description
Participants in this group will recieve magnetic-assisted colonoscopic examination
Intervention Type
Device
Intervention Name(s)
Autonomous navigation of a magnetic colonoscope
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility of magnetic-assisted colonoscope system
Description
The completion rate of colonoscopic examination by using the magnetic-assisted colonoscope system
Time Frame
The end of colonoscopic examination
Title
Safety of magnetic-assisted colonoscope system
Description
The complication rate of colonoscopic examination by using the magnetic-assisted
Time Frame
The end of colonoscopic examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 20-65 health volunteers without any contraindication
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FAT-MOON SUK, M.D.
Phone
+886229307930
Ext
1541
Email
sukfm@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FAT-MOON SUK, M.D.
Organizational Affiliation
Taipei Medical University Wan Fang Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22581127
Citation
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.
Results Reference
background
PubMed Identifier
24648105
Citation
Yang 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.
Results Reference
background
PubMed Identifier
34389760
Citation
Huang 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.
Results Reference
background
PubMed Identifier
29071416
Citation
Lien 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.
Results Reference
background
PubMed Identifier
33742067
Citation
Yen 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.
Results Reference
background
Learn more about this trial
Feasibility Trial of Magnetic-assisted Colonoscope Platform
We'll reach out to this number within 24 hrs