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

Not Applicable

Completed

• Conditions: Gastrointestinal Hemorrhage; Intestinal Diseases

• Registration Number: NCT01872286
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-12
• Study Completion: 2013-02
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-28
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
judgement of normal or abnormal of gastrointestinal tract	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.

Secondary Outcome Measures

Name	Time	Method
diagnostic yield	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.
small-bowel transit time	the comparison was completed 5 weeks after the examination
total number of images captured	the comparison was completed 5 weeks after the examination
complete small-bowel examination rate	5 weeks after the examination
total recording time	5 weeks after the examination
gastric transit time	the comparison was completed 5 weeks after the examination

Trial Locations

Locations (2)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China

Shanghai Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China