Intestinal DiseasesNCT01872286
Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
A study testing AKE-1 and Pillcam SB2 in people with Intestinal Diseases and Gastrointestinal Hemorrhage, run by Changhai Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intestinal Diseases, Gastrointestinal Hemorrhage
- What is being tested?
- AKE-1 and Pillcam SB2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obscure gastrointestinal bleeding
- chronic diarrhea
- suspected Crohn's disease
- chronic abdominal pain
- neoplastic lesions of small bowel
Who cannot join
- patients with any contraindication to capsule endoscopy
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Wuhan Union Hospital
Wuhan, Hubei, 430022
About this study
Official title: A Double-center Randomized Head-to-head 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.
- Conditions
- Intestinal Diseases, Gastrointestinal Hemorrhage
- Being tested
- AKE-1, Pillcam SB2
- Keywords
- Capsule Endoscopy
- Medical subject headings
- Intestinal Diseases, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKE-1Device
Pillcam SB2Device
| Study group | Role | What they receive |
|---|---|---|
| Pillcam SB2 first | Experimental | patients were assigned to swallow PSB first, followed by the AKE Receives: Device: AKE-1; Device: Pillcam SB2 |
| AKE-1 first | Experimental | patients were assigned to swallow AKE first, followed by the PSB Receives: Device: AKE-1; Device: Pillcam SB2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks after the examination
Secondary outcomes (6)
complete small-bowel examination rate
Measured: 5 weeks after the examination
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.
Measured: 5 weeks after the examination
total recording time
Measured: 5 weeks after the examination
gastric transit time
Measured: the comparison was completed 5 weeks after the examination
small-bowel transit time
Measured: the comparison was completed 5 weeks after the examination
total number of images captured
Measured: the comparison was completed 5 weeks after the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Military Medical University, Ministry of Education, China
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhao-Shen Li, Dr., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872286
- Sponsor's protocol ID
- capsule-1
- Status last verified
- Feb 2014
- First submitted
- 4 Jun 2013
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20152309Cave 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.
PubMed 18410941Dolak 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.
PubMed 22930176
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-center Randomized Head-to-head Comparison of the Frequency-altering AKE-1 Capsule and Pillcam SB2
- ClinicalTrials.gov ID
- NCT01872286
- Acronym / sponsor ID
- capsule-1
- Conditions
- Intestinal Diseases, Gastrointestinal Hemorrhage
- Keywords
- Capsule Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Second Military Medical University, Ministry of Education, China
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pillcam SB2 first | Experimental | Device: AKE-1, Device: Pillcam SB2patients were assigned to swallow PSB first, followed by the AKE |
| AKE-1 first | Experimental | Device: AKE-1, Device: Pillcam SB2patients were assigned to swallow AKE first, followed by the PSB |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- obscure gastrointestinal bleeding
- chronic diarrhea
- suspected Crohn's disease
- chronic abdominal pain
- neoplastic lesions of small bowel
Key exclusion criteria (1 listed)
- patients with any contraindication to capsule endoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKE-1 | Device | AKE-1 first, Pillcam SB2 first |
| Pillcam SB2 | Device | AKE-1 first, Pillcam SB2 first |
Primary outcome
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.
6 secondary outcomes
complete small-bowel examination rate
Time frame: 5 weeks after the examination
diagnostic yield
Time frame: 5 weeks after the examination
total recording time
Time frame: 5 weeks after the examination
gastric transit time
Time frame: the comparison was completed 5 weeks after the examination
small-bowel transit time
Time frame: the comparison was completed 5 weeks after the examination
total number of images captured
Time frame: the comparison was completed 5 weeks after the examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Background: PubMed 20152309Liao 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.
- Background: PubMed 18410941Cave 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.
- Background: PubMed 22930176Dolak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhao-Shen Li, Dr. principal investigator
Changhai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKE-1 and Pillcam SB2 in people with Intestinal Diseases and Gastrointestinal Hemorrhage, run by Changhai Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
judgement of normal or abnormal of gastrointestinal tract (time frame: 5 weeks after the examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872286, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2014.