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Remote-controlled Capsule Endoscopy: a Feasibility Study

Primary Purpose

Gastric Ulcer, Gastric Polyp

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
magnetic-controlled capsule endoscopy(Navicam)
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Ulcer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Departement of Gastroenterology, Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Esophagogastroduodenoscopy（ECG）

Arm Description

n=15

Outcomes

Primary Outcome Measures

the percentage of complete visualization of anatomic landmarks
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
examination time and the percentage of abnormal finding
examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy

Secondary Outcome Measures

adverse effect
any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented.
Acceptability
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.

Full Information

First Posted
September 12, 2013
Last Updated
October 28, 2013
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01946633
Brief Title
Remote-controlled Capsule Endoscopy: a Feasibility Study
Official Title
Remote-controlled Capsule Endoscopy: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer, Gastric Polyp

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esophagogastroduodenoscopy（ECG）
Arm Type
Experimental
Arm Description
n=15
Intervention Type
Device
Intervention Name(s)
magnetic-controlled capsule endoscopy(Navicam)
Primary Outcome Measure Information:
Title
the percentage of complete visualization of anatomic landmarks
Description
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
Time Frame
2 year
Title
examination time and the percentage of abnormal finding
Description
examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy
Time Frame
2 year
Secondary Outcome Measure Information:
Title
adverse effect
Description
any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented.
Time Frame
2 year
Title
Acceptability
Description
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.
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xinying Wang, Associate Professor
Phone
86-020-61541540
Email
sunwingwxy@163.com
Facility Information:
Facility Name
Departement of Gastroenterology, Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinying Wang, Associate Professor
Phone
86-020-61541540
Email
sunwingwxy@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21067740
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/21067740
Description
Inspection of the human stomach using remote-controlled capsule endoscopy: a feasibility study in healthy volunteers

Learn more about this trial

Remote-controlled Capsule Endoscopy: a Feasibility Study

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