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

NCT ID: NCT01872286

Last Updated: 2014-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Intestinal Diseases Gastrointestinal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pillcam SB2 first

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

Group Type EXPERIMENTAL

AKE-1

Intervention Type DEVICE

Pillcam SB2

Intervention Type DEVICE

AKE-1 first

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

Group Type EXPERIMENTAL

AKE-1

Intervention Type DEVICE

Pillcam SB2

Intervention Type DEVICE

Interventions

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AKE-1

Intervention Type DEVICE

Pillcam SB2

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Military Medical University

OTHER

Sponsor Role collaborator

Ministry of Education, China

OTHER_GOV

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhao-Shen Li, Dr.

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Wuhan Union Hospital

Wuhan, Hubei, China

Site Status

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 20152309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18410941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22930176 (View on PubMed)

Other Identifiers

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capsule-1

Identifier Type: -

Identifier Source: org_study_id

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