Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
- gastric transit time [the comparison was completed 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]
Other Outcome Measures
- number of adverse events as a measure of safety [2 months after the examination]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wuhan Union Hospital | Wuhan | Hubei | China | 430022 |
| 2 | Shanghai Changhai Hospital | Shanghai | Shanghai | China | 200433 |
Sponsors and Collaborators
- Changhai Hospital
- Second Military Medical University
- Ministry of Education, China
Investigators
- Principal Investigator: Zhao-Shen Li, Dr., Changhai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Cave DR, Fleischer DE, Leighton JA, Faigel DO, Heigh RI, Sharma VK, Gostout CJ, Rajan E, Mergener K, Foley A, Lee M, Bhattacharya K. A multicenter randomized comparison of the Endocapsule and the Pillcam SB. Gastrointest Endosc. 2008 Sep;68(3):487-94. doi: 10.1016/j.gie.2007.12.037. Epub 2008 Apr 14.
- Dolak W, Kulnigg-Dabsch S, Evstatiev R, Gasche C, Trauner M, Püspök A. A randomized head-to-head study of small-bowel imaging comparing MiroCam and EndoCapsule. Endoscopy. 2012 Nov;44(11):1012-20. doi: 10.1055/s-0032-1310158. Epub 2012 Aug 28.
- Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031. Review.
- capsule-1