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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01872286

Enrollment

Registered

2013-06-07

Start date

2011-11-30

Completion date

2013-02-28

Last updated

2014-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Hemorrhage, Intestinal Diseases

Keywords

Capsule Endoscopy

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.

Interventions

DEVICEAKE-1

DEVICEPillcam SB2

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
complete small-bowel examination rate	5 weeks after the examination	—
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.
total recording time	5 weeks after the examination	—
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	—
gastric transit time	the comparison was completed 5 weeks after the examination	—

Other

Measure	Time frame
number of adverse events as a measure of safety	2 months after the examination

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026