NCT06020859

Brief Summary

Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

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

July 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

July 25, 2023

Last Update Submit

August 30, 2023

Conditions

Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

  • the degree of gastric mucosal visualization

    The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, \<70% of the gastric mucosa can be observed.

    2 weeks

Secondary Outcomes (4)

  • The time of gastric examination

    2 weeks

  • detection of lesions

    2 weeks

  • Equipment operation evaluation

    2 weeks

  • Safety Assessment

    2 weeks

Study Arms (3)

NaviEC-2000Pro Gastro Scan

EXPERIMENTAL

NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro

Device: undergo NaviEC-2000Pro Gastro Scan mode

NaviEC-2000Pro Routine gastric examination

EXPERIMENTAL

NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro

Device: NaviEC-2000Pro Routine gastric examination

NaviEC-1000 Routine gastric examination

ACTIVE COMPARATOR

NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000

Device: NaviEC-1000 Routine gastric examination

Interventions

undergo NaviEC-2000Pro Gastro Scan modeDEVICE

Patients undergo NaviEC-2000Pro Gastro Scan mode.

NaviEC-2000Pro Gastro Scan
NaviEC-2000Pro Routine gastric examinationDEVICE

Patients undergo NaviEC-2000Pro Routine gastric examination mode.

NaviEC-2000Pro Routine gastric examination
NaviEC-1000 Routine gastric examinationDEVICE

Patients undergo NaviEC-1000 Routine gastric examination mode.

NaviEC-1000 Routine gastric examination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • underwent gastric examination;
  • At least 18 years old；
  • Be able to provide informed consent.

You may not qualify if:

  • With swallowing obstruction or disorders;
  • With known or suspected gastrointestinal obstruction, stenosis and fistula;
  • Have no conditions for surgery or refuse to undergo any abdominal surgery;
  • Be allergic to or have other known contraindication or intolerance to the drug used in the study;
  • With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
  • Women during pregnancy;
  • Currently enrolled in another clinical trial of a drug or device;
  • Other conditions determined by the investigator to be inappropriate for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.

    PMID: 30005825BACKGROUND

  • Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.

    PMID: 27211503BACKGROUND

Central Study Contacts

Zhuan Liao

CONTACT

86-21-31161004liaozhuan@smmu.edu.cn

Yangyang Qian

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2023

First Posted

September 1, 2023

Study Start

August 30, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

September 1, 2023

Record last verified: 2023-08