Remote-controlled Capsule Endoscopy: a Feasibility Study

NCT ID: NCT01946633

Last Updated: 2013-10-30

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy.

The product was developed and manufacture in China.(the NaviCam. AKC-1.China)

Detailed Description

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Conditions

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Gastric Ulcer Gastric Polyp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Esophagogastroduodenoscopy(ECG)

n=15

Group Type EXPERIMENTAL

magnetic-controlled capsule endoscopy(Navicam)

Intervention Type DEVICE

Interventions

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magnetic-controlled capsule endoscopy(Navicam)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* upper abdominal symptoms (≥1 year )
* surveillance gastroscopy for known gastric ulcer or polyps
* history of gastric ulcer or polyps (≤1w)at Nanfang Hospital were enrolled.

Exclusion Criteria

* dysphagia
* suspected or documented digestive tract malformation ,obstruction, strictures or fistula
* acute upper GI bleeding, acute enteritis, acute ischemia disease
* history of abdominal operations
* impaired renal function, congestive heart failure
* patients with critical condition or mental illness
* patients with, known allergy to polymer material or antifoam agent
* patients with cardiac pacemakers or other implanted electromedical devices,magnetic resonance imaging ( mri) examination in 7 days
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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xinying wang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Departement of Gastroenterology, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xinying Wang, Associate Professor

Role: CONTACT

Phone: 86-020-61541540

Email: [email protected]

Facility Contacts

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Xinying Wang, Associate Professor

Role: primary

References

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Keller J, Fibbe C, Volke F, Gerber J, Mosse AC, Reimann-Zawadzki M, Rabinovitz E, Layer P, Schmitt D, Andresen V, Rosien U, Swain P. Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers (with videos). Gastrointest Endosc. 2011 Jan;73(1):22-8. doi: 10.1016/j.gie.2010.08.053. Epub 2010 Nov 9.

Reference Type BACKGROUND
PMID: 21067740 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/21067740

Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers

Other Identifiers

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GNF-NaviCam-001

Identifier Type: -

Identifier Source: org_study_id