Remote-controlled Capsule Endoscopy: a Feasibility Study

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Gastric Polyp; Gastric Ulcer

Treatments: Device: magnetic-controlled capsule endoscopy(Navicam)

Study type: Interventional

Funder types: Other

Identifiers

NCT01946633

GNF-NaviCam-001

Details and patient eligibility

About

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)

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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80 participants in 1 patient group

Esophagogastroduodenoscopy（ECG）

Experimental group

Description:

n=15

Treatment:

Device: magnetic-controlled capsule endoscopy(Navicam)