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

Naval Military Medical University

Status: Completed

Conditions: Intestinal Diseases; Gastrointestinal Hemorrhage

Treatments: Device: Pillcam SB2; Device: AKE-1

Study type: Interventional

Funder types: Other

Identifiers

NCT01872286

capsule-1

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

Pillcam SB2 first

Experimental group

Description:

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

Treatment:

Device: Pillcam SB2

Device: AKE-1

AKE-1 first

Experimental group

Description:

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

Treatment:

Device: Pillcam SB2

Device: AKE-1