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

Primary Purpose

Intestinal Diseases, Gastrointestinal Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AKE-1
Pillcam SB2
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intestinal Diseases focused on measuring Capsule Endoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wuhan Union Hospital
  • Shanghai Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pillcam SB2 first

AKE-1 first

Arm Description

patients were assigned to swallow PSB first, followed by the AKE

patients were assigned to swallow AKE first, followed by the PSB

Outcomes

Primary Outcome Measures

judgement of normal or abnormal of gastrointestinal tract
If a lesion is detected by capsule endoscopy in gastrointestinal tract in a patient, the result will be judged as abnormal.

Secondary Outcome Measures

complete small-bowel examination rate
diagnostic yield
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.
total recording time
gastric transit time
small-bowel transit time
total number of images captured

Full Information

First Posted
June 4, 2013
Last Updated
February 28, 2014
Sponsor
Changhai Hospital
Collaborators
Second Military Medical University, Ministry of Education, China
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1. Study Identification

Unique Protocol Identification Number
NCT01872286
Brief Title
Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
Official Title
A Double-center Randomized Head-to-head Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
Second Military Medical University, Ministry of Education, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Diseases, Gastrointestinal Hemorrhage
Keywords
Capsule Endoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pillcam SB2 first
Arm Type
Experimental
Arm Description
patients were assigned to swallow PSB first, followed by the AKE
Arm Title
AKE-1 first
Arm Type
Experimental
Arm Description
patients were assigned to swallow AKE first, followed by the PSB
Intervention Type
Device
Intervention Name(s)
AKE-1
Intervention Type
Device
Intervention Name(s)
Pillcam SB2
Primary Outcome Measure Information:
Title
judgement of normal or abnormal of gastrointestinal tract
Description
If a lesion is detected by capsule endoscopy in gastrointestinal tract in a patient, the result will be judged as abnormal.
Time Frame
5 weeks after the examination
Secondary Outcome Measure Information:
Title
complete small-bowel examination rate
Time Frame
5 weeks after the examination
Title
diagnostic yield
Description
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.
Time Frame
5 weeks after the examination
Title
total recording time
Time Frame
5 weeks after the examination
Title
gastric transit time
Time Frame
the comparison was completed 5 weeks after the examination
Title
small-bowel transit time
Time Frame
the comparison was completed 5 weeks after the examination
Title
total number of images captured
Time Frame
the comparison was completed 5 weeks after the examination
Other Pre-specified Outcome Measures:
Title
number of adverse events as a measure of safety
Time Frame
2 months after the examination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao-Shen Li, Dr.
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20152309
Citation
Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031.
Results Reference
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PubMed Identifier
18410941
Citation
Cave DR, Fleischer DE, Leighton JA, Faigel DO, Heigh RI, Sharma VK, Gostout CJ, Rajan E, Mergener K, Foley A, Lee M, Bhattacharya K. A multicenter randomized comparison of the Endocapsule and the Pillcam SB. Gastrointest Endosc. 2008 Sep;68(3):487-94. doi: 10.1016/j.gie.2007.12.037. Epub 2008 Apr 14.
Results Reference
background
PubMed Identifier
22930176
Citation
Dolak W, Kulnigg-Dabsch S, Evstatiev R, Gasche C, Trauner M, Puspok A. A randomized head-to-head study of small-bowel imaging comparing MiroCam and EndoCapsule. Endoscopy. 2012 Nov;44(11):1012-20. doi: 10.1055/s-0032-1310158. Epub 2012 Aug 28.
Results Reference
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Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2

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