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

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ClinicalTrials.gov Identifier: NCT01872286
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : March 3, 2014
Sponsor:
Collaborators:
Second Military Medical University
Ministry of Education, China
Information provided by (Responsible Party):
Zhaoshen Li, 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.

Condition or disease Intervention/treatment Phase
Intestinal Diseases Gastrointestinal Hemorrhage Device: AKE-1 Device: Pillcam SB2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Double-center Randomized Head-to-head Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
Drug Information available for: Infliximab

Arm Intervention/treatment
Experimental: Pillcam SB2 first
patients were assigned to swallow PSB first, followed by the AKE
Device: AKE-1
Device: Pillcam SB2
Experimental: AKE-1 first
patients were assigned to swallow AKE first, followed by the PSB
Device: AKE-1
Device: Pillcam SB2



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. number of adverse events as a measure of safety [ Time Frame: 2 months after the examination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872286


Locations
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China, Hubei
Wuhan Union Hospital
Wuhan, Hubei, China, 430022
China, Shanghai
Shanghai Changhai Hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Second Military Medical University
Ministry of Education, China
Investigators
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Principal Investigator: Zhao-Shen Li, Dr. Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Publications:
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Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept., Changhai Hospital
ClinicalTrials.gov Identifier: NCT01872286     History of Changes
Other Study ID Numbers: capsule-1
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: March 3, 2014
Last Verified: February 2014

Keywords provided by Zhaoshen Li, Changhai Hospital:
Capsule Endoscopy

Additional relevant MeSH terms:
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Hemorrhage
Gastrointestinal Hemorrhage
Intestinal Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases