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NCT01946633 Clinical Trial

Remote-controlled Capsule Endoscopy: a Feasibility Study

Gastric Ulcer Clinical Trial

Official title:
Remote-controlled Capsule Endoscopy: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01946633
Other study ID # GNF-NaviCam-001
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2013
Last updated October 28, 2013
Start date October 2013

Study information
Verified date October 2013
Source Nanfang Hospital of Southern Medical University
Contact xinying Wang, Associate Professor
Phone 86-020-61541540
Email sunwingwxy@163.com
Is FDA regulated No
Health authority China:Institutional Review Board of Nanfang Hospital, Southern Medical University
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• magnetic-controlled capsule endoscopy(Navicam)

Locations
Country Name City State
China Departement of Gastroenterology, Nanfang Hospital, Southern Medical University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 year No
Primary 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 2 year No
Secondary adverse effect any discomfort like chest pain, nausea will be documented. capsule retention(defined as not extrusion in 14 days)will be documented. 2 year Yes
Secondary 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. 2 year Yes
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