Remote-controlled Capsule Endoscopy: a Feasibility Study
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|ClinicalTrials.gov Identifier: NCT01946633|
Recruitment Status : Unknown
Verified October 2013 by xinying wang, Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : September 19, 2013
Last Update Posted : October 30, 2013
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)
|Condition or disease||Intervention/treatment||Phase|
|Gastric Ulcer Gastric Polyp||Device: magnetic-controlled capsule endoscopy(Navicam)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Remote-controlled Capsule Endoscopy: a Feasibility Study|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||September 2014|
Device: magnetic-controlled capsule endoscopy(Navicam)
- 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
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946633
|Contact: xinying Wang, Associate Professorfirstname.lastname@example.org|
|Departement of Gastroenterology, Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Xinying Wang, Associate Professor 86-020-61541540 email@example.com|