NCT01872286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
Last Updated

March 3, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

June 4, 2013

Last Update Submit

February 28, 2014

Conditions

Intestinal DiseasesGastrointestinal Hemorrhage

Keywords

Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • complete small-bowel examination rate

    5 weeks after the examination

  • diagnostic yield

    5 weeks after the examination

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • number of adverse events as a measure of safety

    2 months after the examination

Study Arms (2)

Pillcam SB2 first

EXPERIMENTAL

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

Device: AKE-1Device: Pillcam SB2

AKE-1 first

EXPERIMENTAL

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

Device: AKE-1Device: Pillcam SB2

Interventions

AKE-1DEVICE
AKE-1 firstPillcam SB2 first
Pillcam SB2DEVICE
AKE-1 firstPillcam SB2 first

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obscure gastrointestinal bleeding
  • chronic diarrhea
  • suspected Crohn's disease
  • chronic abdominal pain
  • neoplastic lesions of small bowel

You may not qualify if:

  • patients with any contraindication to capsule endoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

  • 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.

    PMID: 20152309BACKGROUND

  • 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.

    PMID: 18410941BACKGROUND

  • Dolak W, Kulnigg-Dabsch S, Evstatiev R, Gasche C, Trauner M, Puspok 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.

    PMID: 22930176BACKGROUND

MeSH Terms

Conditions

Intestinal DiseasesGastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhao-Shen Li, Dr.

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept.

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 7, 2013

Study Start

November 1, 2011

Primary Completion

December 1, 2012

Study Completion

February 1, 2013

Last Updated

March 3, 2014

Record last verified: 2014-02

Locations

CN(2)