Remote-controlled Capsule Endoscopy: a Feasibility Study

Not Applicable

• Conditions: Gastric Ulcer; Gastric Polyp
• Interventions: Device: magnetic-controlled capsule endoscopy(Navicam)

• Registration Number: NCT01946633
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Status Verified: 2013-10
• Study Start: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-30
• Primary Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esophagogastroduodenoscopy（ECG）	magnetic-controlled capsule endoscopy(Navicam)	n=15

Primary Outcome Measures

Name	Time	Method
the percentage of complete visualization of anatomic landmarks	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	2 year	examination time and the percentage of abnormal findings seen on gastroscopy that were reproducible by capsule endoscopy

Secondary Outcome Measures

Name	Time	Method
adverse effect	2 year	any discomfort like chest pain, nausea will be documented. capsule retention（defined as not extrusion in 14 days）will be documented.
Acceptability	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.

Trial Locations

Locations (1)

Departement of Gastroenterology, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China