Remote-controlled Capsule Endoscopy: a Feasibility Study
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946633
|Contact: xinying Wang, Associate Professoremail@example.com|
|Departement of Gastroenterology, Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Xinying Wang, Associate Professor 86-020-61541540 firstname.lastname@example.org|