MCE-new for Detection of Gastric Lesions

NCT ID: NCT06020859

Last Updated: 2023-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2024-11-30

Brief Summary

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

Detailed Description

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The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.

Conditions

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Capsule Endoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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NaviEC-2000Pro Gastro Scan

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

Group Type EXPERIMENTAL

undergo NaviEC-2000Pro Gastro Scan mode

Intervention Type DEVICE

Patients undergo NaviEC-2000Pro Gastro Scan mode.

NaviEC-2000Pro Routine gastric examination

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

Group Type EXPERIMENTAL

NaviEC-2000Pro Routine gastric examination

Intervention Type DEVICE

Patients undergo NaviEC-2000Pro Routine gastric examination mode.

NaviEC-1000 Routine gastric examination

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

Group Type ACTIVE_COMPARATOR

NaviEC-1000 Routine gastric examination

Intervention Type DEVICE

Patients undergo NaviEC-1000 Routine gastric examination mode.

Interventions

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undergo NaviEC-2000Pro Gastro Scan mode

Patients undergo NaviEC-2000Pro Gastro Scan mode.

Intervention Type DEVICE

NaviEC-2000Pro Routine gastric examination

Patients undergo NaviEC-2000Pro Routine gastric examination mode.

Intervention Type DEVICE

NaviEC-1000 Routine gastric examination

Patients undergo NaviEC-1000 Routine gastric examination mode.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Liao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Zhuan Liao

Role: CONTACT

86-21-31161004

Yangyang Qian

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 30005825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27211503 (View on PubMed)

Other Identifiers

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MCE-new

Identifier Type: -

Identifier Source: org_study_id

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