Remote-controlled Capsule Endoscopy: a Feasibility Study

October 28, 2013 updated by: xinying wang, Nanfang Hospital of Southern Medical University

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xinying Wang, Associate Professor
  • Phone Number: 86-020-61541540
  • Email: sunwingwxy@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Departement of Gastroenterology, Nanfang Hospital, Southern Medical University
        • Contact:
          • Xinying Wang, Associate Professor
          • Phone Number: 86-020-61541540
          • Email: sunwingwxy@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esophagogastroduodenoscopy（ECG）
n=15
Device: magnetic-controlled capsule endoscopy(Navicam)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of complete visualization of anatomic landmarks
Time Frame: 2 year
the percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
2 year
examination time and the percentage of abnormal finding
Time Frame: 2 year
examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse effect
Time Frame: 2 year
any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented.
2 year
Acceptability
Time Frame: 2 year
Acceptability to patients was assessed by means of a questionnaire, with ratings on a scale of 0 to 10 and examination chosen for next time. completed in the recovery room immediately after capsule examination.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNF-NaviCam-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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