Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2

February 28, 2014 updated by: Zhaoshen Li, Changhai Hospital

A Double-center Randomized Head-to-head Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2

Capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel disease. This study was aimed to compare the performance between the frequency-altering AKE-1 capsule and the Pillcam SB2 in patients with suspected small bowel disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Shanghai Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • obscure gastrointestinal bleeding
  • chronic diarrhea
  • suspected Crohn's disease
  • chronic abdominal pain
  • neoplastic lesions of small bowel

Exclusion Criteria:

  • patients with any contraindication to capsule endoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pillcam SB2 first
patients were assigned to swallow PSB first, followed by the AKE
Device: AKE-1
Device: Pillcam SB2
Experimental: AKE-1 first
patients were assigned to swallow AKE first, followed by the PSB
Device: AKE-1
Device: Pillcam SB2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
judgement of normal or abnormal of gastrointestinal tract
Time Frame: 5 weeks after the examination
If a lesion is detected by capsule endoscopy in gastrointestinal tract in a patient, the result will be judged as abnormal.
5 weeks after the examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete small-bowel examination rate
Time Frame: 5 weeks after the examination
5 weeks after the examination
diagnostic yield
Time Frame: 5 weeks after the examination
The finding that could explain the symptom and resulted in clinical impact was considered as diagnosis.Diagnostic yield of a capsule endoscopy is the proportion of patients with positive diagnosis over total patients.
5 weeks after the examination
total recording time
Time Frame: 5 weeks after the examination
5 weeks after the examination
gastric transit time
Time Frame: the comparison was completed 5 weeks after the examination
the comparison was completed 5 weeks after the examination
small-bowel transit time
Time Frame: the comparison was completed 5 weeks after the examination
the comparison was completed 5 weeks after the examination
total number of images captured
Time Frame: the comparison was completed 5 weeks after the examination
the comparison was completed 5 weeks after the examination

Other Outcome Measures

Outcome Measure
Time Frame
number of adverse events as a measure of safety
Time Frame: 2 months after the examination
2 months after the examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Second Military Medical University
Ministry of Education, China

Investigators

  • Principal Investigator: Zhao-Shen Li, Dr., Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • capsule-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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