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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01872286
Other study ID # capsule-1
Secondary ID
Status Completed
Phase N/A
First received June 4, 2013
Last updated February 28, 2014
Start date November 2011
Est. completion date February 2013

Study information

Verified date February 2014
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date February 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
AKE-1

Pillcam SB2


Locations

Country Name City State
China Shanghai Changhai Hospital Shanghai Shanghai
China Wuhan Union Hospital Wuhan Hubei

Sponsors (3)

Lead Sponsor Collaborator
Changhai Hospital Ministry of Education, China, Second Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Dolak W, Kulnigg-Dabsch S, Evstatiev R, Gasche C, Trauner M, Püspök 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other number of adverse events as a measure of safety 2 months after the examination Yes
Primary 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. 5 weeks after the examination No
Secondary complete small-bowel examination rate 5 weeks after the examination No
Secondary 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. 5 weeks after the examination No
Secondary total recording time 5 weeks after the examination No
Secondary gastric transit time the comparison was completed 5 weeks after the examination No
Secondary small-bowel transit time the comparison was completed 5 weeks after the examination No
Secondary total number of images captured the comparison was completed 5 weeks after the examination No
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