Gastric SymptomsPhase 1/2NCT01903629
Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy
A Phase 1/2 study testing MCE and Standard gastroscopy in people with Gastric Symptoms and Indicated for Upper GI Endoscopy, run by Changhai Hospital at 1 site in China.
Trial summary
Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Symptoms, Indicated for Upper GI Endoscopy
- What is being tested?
- MCE and Standard gastroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Feb 2013
- Phase
- Phase 1/2
- 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
- Patients with gastric symptoms and indicated for Upper GI endoscopy
- Age of 18 years to 70 years
Who cannot join
- Patients with impaired bowel movement from ileus or organic digestive diseases
- Patients with known large and obstructing tumors of the upper GI tract
- Patients after upper GI surgery or abdominal surgery altering GI anatomy
- Patients under full anticoagulation
- Patient in poor general condition
- Patients using equipment that may be affected by radio transmission
- Patients using equipment that may be affected by magnetic field
- Pregnancy or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-center Self-controlled Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy for Gastric Diseases
Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.
- Conditions
- Gastric Symptoms, Indicated for Upper GI Endoscopy
- Being tested
- MCE, Standard gastroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCEDevice
MCE first, followed by standard gastroscopy
Standard gastroscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| magnetic-controlled capsule endoscocpy (MCE) | Experimental | patients were assigned to swallow MCE first, followed by the gastroscopy Receives: Device: MCE; Device: Standard gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions
Measured: 2 days
Secondary outcomes (3)
Examination times of capsule and standard gastroscopy
Measured: 1 hour
Patient acceptance of capsule gastroscopy and standard gastroscopy
Measured: 3 days
Adverse events of both procedures
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 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 Gastric SymptomsStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Military Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903629
- Sponsor's protocol ID
- AKE-1
- Status last verified
- Jul 2015
- First submitted
- 17 Jul 2013
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.
PubMed 23687601Liao 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 20152309Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.
PubMed 25590177
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-center Self-controlled Comparative Study of the Magnetic-controlled Capsule Endoscopy Versus Standard Gastroscopy for Gastric Diseases
- ClinicalTrials.gov ID
- NCT01903629
- Acronym / sponsor ID
- AKE-1
- Conditions
- Gastric Symptoms, Indicated for Upper GI Endoscopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Second Military Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Jul 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.
Passive video capsule endoscopy is the criterion standard for small-bowel diseases but cannot be used for the large gastric cavity.This blinded prospective study investigates the accuracy of the magnetic-controlled capsule endoscopy compared to gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| magnetic-controlled capsule endoscocpy (MCE) | Experimental | Device: MCE, Device: Standard gastroscopypatients were assigned to swallow MCE first, followed by the gastroscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with gastric symptoms and indicated for Upper GI endoscopy
- Age of 18 years to 70 years
Key exclusion criteria (8 listed)
- Patients with impaired bowel movement from ileus or organic digestive diseases
- Patients with known large and obstructing tumors of the upper GI tract
- Patients after upper GI surgery or abdominal surgery altering GI anatomy
- Patients under full anticoagulation
- Patient in poor general condition
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 |
|---|---|---|
| MCEMCE first, followed by standard gastroscopy | Device | magnetic-controlled capsule endoscocpy (MCE) |
| Standard gastroscopy | Device | magnetic-controlled capsule endoscocpy (MCE) |
Primary outcome
Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions
Time frame: 2 days
3 secondary outcomes
Examination times of capsule and standard gastroscopy
Time frame: 1 hour
Patient acceptance of capsule gastroscopy and standard gastroscopy
Time frame: 3 days
Adverse events of both procedures
Time frame: 2 weeks
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 21 Jul 2015.
- Background: PubMed 23687601Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.
- 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.
- Derived from this study: PubMed 25590177Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MCE and Standard gastroscopy in people with Gastric Symptoms and Indicated for Upper GI Endoscopy, run by Changhai Hospital at 1 site 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 2 inclusion and 8 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 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Accuracy of magnetic-controlled capsule endoscopy(MCE) Versus Standard Gastroscopy in the diagnosis of diffuse and local lesions (time frame: 2 days). 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 NCT01903629, 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 21 Jul 2015.