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

Gastrointestinal Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872286
• Other study ID #: capsule-1
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: February 28, 2014
• Start date: November 2011
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Intestinal Diseases

Intervention

Device:
• AKE-1

• Pillcam SB2

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (3)

Lead Sponsor	Collaborator
Changhai Hospital	Ministry of Education, China, Second Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of adverse events as a measure of safety		2 months after the examination	Yes
Primary	judgement of normal or abnormal of gastrointestinal tract	If a lesion is detected by capsule endoscopy in gastrointestinal tract in a patient, the result will be judged as abnormal.	5 weeks after the examination	No
Secondary	complete small-bowel examination rate		5 weeks after the examination	No
Secondary	diagnostic yield	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.	5 weeks after the examination	No
Secondary	total recording time		5 weeks after the examination	No
Secondary	gastric transit time		the comparison was completed 5 weeks after the examination	No
Secondary	small-bowel transit time		the comparison was completed 5 weeks after the examination	No
Secondary	total number of images captured		the comparison was completed 5 weeks after the examination	No