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Feasibility Trial of Magnetic-assisted Colonoscope Platform

Studies

Study First Submitted Date 2022-01-27
Study First Posted Date 2022-01-28
Last Update Posted Date 2023-04-20
Start Month Year May 2024
Primary Completion Month Year December 2024
Verification Month Year April 2023
Verification Date 2023-04-30
Last Update Posted Date 2023-04-20

Detailed Descriptions

Sequence: 20571294
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

Sequence: 51783706 Sequence: 51783707
Name Colonoscopy Name Colorectal Cancer
Downcase Name colonoscopy Downcase Name colorectal cancer

Id Information

Sequence: 39850427
Id Source org_study_id
Id Value N202004113

Design Groups

Sequence: 55203172
Group Type Experimental
Title Magnetic-assisted colonoscopy group
Description Participants in this group will recieve magnetic-assisted colonoscopic examination

Interventions

Sequence: 52105932
Intervention Type Device
Name Autonomous navigation of a magnetic colonoscope
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

Keywords

Sequence: 79233385 Sequence: 79233386
Name Colonoscopy Name Magnetic-assisted
Downcase Name colonoscopy Downcase Name magnetic-assisted

Design Outcomes

Sequence: 176128935 Sequence: 176128936
Outcome Type primary Outcome Type primary
Measure Feasibility of magnetic-assisted colonoscope system Measure Safety of magnetic-assisted colonoscope system
Time Frame The end of colonoscopic examination Time Frame The end of colonoscopic examination
Description The completion rate of colonoscopic examination by using the magnetic-assisted colonoscope system Description The complication rate of colonoscopic examination by using the magnetic-assisted

Browse Conditions

Sequence: 191926501 Sequence: 191926502 Sequence: 191926503 Sequence: 191926504 Sequence: 191926505 Sequence: 191926506 Sequence: 191926507 Sequence: 191926508 Sequence: 191926509 Sequence: 191926510 Sequence: 191926511
Mesh Term Colorectal Neoplasms Mesh Term Intestinal Neoplasms Mesh Term Gastrointestinal Neoplasms Mesh Term Digestive System Neoplasms Mesh Term Neoplasms by Site Mesh Term Neoplasms Mesh Term Digestive System Diseases Mesh Term Gastrointestinal Diseases Mesh Term Colonic Diseases Mesh Term Intestinal Diseases Mesh Term Rectal Diseases
Downcase Mesh Term colorectal neoplasms Downcase Mesh Term intestinal neoplasms Downcase Mesh Term gastrointestinal neoplasms Downcase Mesh Term digestive system neoplasms Downcase Mesh Term neoplasms by site Downcase Mesh Term neoplasms Downcase Mesh Term digestive system diseases Downcase Mesh Term gastrointestinal diseases Downcase Mesh Term colonic diseases Downcase Mesh Term intestinal diseases Downcase Mesh Term rectal diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47957866 Sequence: 47957867
Agency Class OTHER Agency Class OTHER_GOV
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Taipei Medical University WanFang Hospital Name Ministry of Health and Welfare, Taiwan

Overall Officials

Sequence: 29056861
Role Principal Investigator
Name FAT-MOON SUK, M.D.
Affiliation Taipei Medical University Wan Fang Hospital

Central Contacts

Sequence: 11930766
Contact Type primary
Name FAT-MOON SUK, M.D.
Phone +886229307930
Email sukfm@yahoo.com
Phone Extension 1541
Role Contact

Design Group Interventions

Sequence: 67680248
Design Group Id 55203172
Intervention Id 52105932

Eligibilities

Sequence: 30537980
Gender All
Minimum Age 20 Years
Maximum Age 65 Years
Healthy Volunteers Accepts Healthy Volunteers
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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254186032
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 20
Maximum Age Num 65
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 2

Designs

Sequence: 30286518
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Device Feasibility
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 28665474
Responsible Party Type Principal Investigator
Name Fat-Moon Suk
Title Attending physician
Affiliation Taipei Medical University WanFang Hospital

Study References

Sequence: 51678505 Sequence: 51678506 Sequence: 51678507 Sequence: 51678508 Sequence: 51678509
Pmid 22581127 Pmid 24648105 Pmid 34389760 Pmid 29071416 Pmid 33742067
Reference Type background Reference Type background Reference Type background Reference Type background Reference Type background
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. 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. 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. 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. 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.