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Completed

NCT Number: NCT01872286

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

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.

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Key information

Conditions

Intestinal Diseases Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Union Hospital, Wuhan, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AKE-1

Device

Pillcam SB2

Device

Primary outcomes

  1. judgement of normal or abnormal of gastrointestinal tract

    Time frame: 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 outcomes

  1. complete small-bowel examination rate

    Time frame: 5 weeks after the examination

  2. diagnostic yield

    Time frame: 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.

  3. total recording time

    Time frame: 5 weeks after the examination

  4. gastric transit time

    Time frame: the comparison was completed 5 weeks after the examination

  5. small-bowel transit time

    Time frame: the comparison was completed 5 weeks after the examination

  6. total number of images captured

    Time frame: the comparison was completed 5 weeks after the examination

Other outcomes

  1. number of adverse events as a measure of safety

    Time frame: 2 months after the examination

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • Ministry of Education, China
  • Second Military Medical University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 7, 2013
Registry last updated
Mar 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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