Remote-controlled Capsule Endoscopy: a Feasibility Study
Recruitment status was: Recruiting
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)
Device: magnetic-controlled capsule endoscopy(Navicam)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Remote-controlled Capsule Endoscopy: a Feasibility Study|
- the percentage of complete visualization of anatomic landmarks [ Time Frame: 2 year ] [ Designated as safety issue: No ]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 [ Time Frame: 2 year ] [ Designated as safety issue: No ]examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy
- adverse effect [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented.
- Acceptability [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
|Device: magnetic-controlled capsule endoscopy(Navicam)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946633
|Departement of Gastroenterology, Nanfang Hospital, Southern Medical University|
|Guangzhou, Guangdong, China, 510515|