Remote-controlled Capsule Endoscopy: a Feasibility Study

This study is currently recruiting participants.
Verified October 2013 by Nanfang Hospital of Southern Medical University
Sponsor:
Information provided by (Responsible Party):
xinying wang, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01946633
First received: September 12, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 Intervention
Gastric Ulcer
Gastric Polyp
Device: magnetic-controlled capsule endoscopy(Navicam)

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: October 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esophagogastroduodenoscopy(ECG)
n=15
Device: magnetic-controlled capsule endoscopy(Navicam)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01946633

Contacts
Contact: xinying Wang, Associate Professor 86-020-61541540 sunwingwxy@163.com

Locations
China, Guangdong
Departement of Gastroenterology, Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Xinying Wang, Associate Professor    86-020-61541540    sunwingwxy@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
  More Information

Additional Information:
Publications:
Responsible Party: xinying wang, Associate Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01946633     History of Changes
Other Study ID Numbers: GNF-NaviCam-001
Study First Received: September 12, 2013
Last Updated: October 28, 2013
Health Authority: China:Institutional Review Board of Nanfang Hospital, Southern Medical University

Additional relevant MeSH terms:
Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014