Remote-controlled Capsule Endoscopy: a Feasibility Study
1 other identifier
interventional
80
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 19, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedOctober 30, 2013
October 1, 2013
11 months
September 12, 2013
October 28, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Secondary Outcomes (2)
adverse effect
2 year
Acceptability
2 year
Study Arms (1)
Esophagogastroduodenoscopy（ECG）
EXPERIMENTALn=15
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departement of Gastroenterology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related 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.
PMID: 21067740BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 19, 2013
Study Start
October 1, 2013
Primary Completion
September 1, 2014
Last Updated
October 30, 2013
Record last verified: 2013-10