Remote-controlled Capsule Endoscopy: a Feasibility Study

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014