NCT05213741

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

January 27, 2022

Last Update Submit

April 19, 2023

Conditions

ColonoscopyColorectal Cancer

Keywords

ColonoscopyMagnetic-assisted

Outcome Measures

Primary Outcomes (2)

  • Feasibility of magnetic-assisted colonoscope system

    The completion rate of colonoscopic examination by using the magnetic-assisted colonoscope system

    The end of colonoscopic examination

  • Safety of magnetic-assisted colonoscope system

    The complication rate of colonoscopic examination by using the magnetic-assisted

    The end of colonoscopic examination

Study Arms (1)

Magnetic-assisted colonoscopy group

EXPERIMENTAL

Participants in this group will recieve magnetic-assisted colonoscopic examination

Device: Autonomous navigation of a magnetic colonoscope

Interventions

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

Magnetic-assisted colonoscopy group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20-65 health volunteers without any contraindication

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 22581127BACKGROUND

  • 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.

    PMID: 24648105BACKGROUND

  • 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.

    PMID: 34389760BACKGROUND

  • 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.

    PMID: 29071416BACKGROUND

  • 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.

    PMID: 33742067BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • FAT-MOON SUK, M.D.

    Taipei Medical University Wan Fang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FAT-MOON SUK, M.D.

CONTACT

+886229307930sukfm@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

January 27, 2022

First Posted

January 28, 2022

Study Start

May 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share