Gastric Diseases,Phase 3MCENCT02219529
Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases
A Phase 3 study testing MCE and Standard gastroscopy in people with Gastric Diseases, and Gastric Ulcer,, run by Changhai Hospital at 1 site in China.
Trial summary
A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Diseases,, Gastric Ulcer,, Gastric Polyps,
- What is being tested?
- MCE and Standard gastroscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Feb 2015
- Phase
- Phase 3
- 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 presented with gastric symptoms and ready for the first Upper GI endoscopy
- Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.
- 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: Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial
A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with gastroscopy in patients with gastric symptoms and indication for upper GI Endoscopy.
- Conditions
- Gastric Diseases,, Gastric Ulcer,, Gastric Polyps,, Early Gastric Cancer,, Chronic Gastritis
- Being tested
- MCE, Standard gastroscopy
- Medical subject headings
- Stomach Diseases, Stomach Ulcer, Polyposis, Gastric, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCEDevice
Also called magnetic-controlled capsule endoscopy
Standard gastroscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| MCE | Experimental | patients were assigned to swallow MCE first, followed by the gastroscopy Receives: Device: MCE |
| Standard gastroscopy | Active comparator | patients were assigned to swallow MCE first, followed by the gastroscopy Receives: Device: Standard gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
Measured: 2 days
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
Measured: 2 days
Secondary outcomes (6)
Volume of water and drugs used for gastric preparation
Measured: 1 hour
Scores of the cleanliness of stomach after preparation
Measured: 1 day
Percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
Measured: 1 day
Examination times of MCE and standard gastroscopy
Measured: 1 day
Patient acceptance of MCE 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 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2015
- Study completionFeb 2015
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 Diseases,Studies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Nanfang Hospital, Southern Medical University, Chinese PLA General Hospital, General Hospital of Beijing PLA Military Region, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shandong Provincial Hospital, Peking Union Medical College Hospital
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Zhaoshen Li, Prof., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219529
- Sponsor's protocol ID
- MCE-1
- Acronym
- MCE
- Status last verified
- Jul 2015
- First submitted
- 12 Aug 2014
- 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 20152309Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
PubMed 27211503
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
- Magnetic-controlled Capsule Endoscopy vs. Gastroscopy for Detection of Gastric Diseases: A Prospective Self-controlled Comparative Multicenter Trial
- ClinicalTrials.gov ID
- NCT02219529
- Acronym / sponsor ID
- MCE / MCE-1
- Conditions
- Gastric Diseases,, Gastric Ulcer,, Gastric Polyps,, Early Gastric Cancer,, Chronic Gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Nanfang Hospital, Southern Medical University, Chinese PLA General Hospital, General Hospital of Beijing PLA Military Region, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Shandong Provincial Hospital, Peking Union Medical College Hospital
- Study start
- Aug 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Aug 2014 (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.
A new Magnetic-controlled Capsule Endoscopy (MCE) was developed by ANKON and got SFDA's approval in China in 2013. It has recently been evaluated to compare the diagnostic accuracy of MCE with that of standard gastroscopy for gastric diseases in 70 patients with encouraging results (In Press). To further testify the diagnostic accuracy of MCE for both the diffuse and focal diseases in stomach, we performed this single-blinded multi-center prospective study compared MCE with 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 (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCE | Experimental | Device: MCEpatients were assigned to swallow MCE first, followed by the gastroscopy |
| Standard gastroscopy | Active comparator | 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 (3 listed)
- Patients presented with gastric symptoms and ready for the first Upper GI endoscopy
- Patients with known focal gastric diseases: gastric ulcer, gastric polyps, early gastric cancer, gastric stromal tumors and so on.
- 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 |
|---|---|---|
| MCEAlso: magnetic-controlled capsule endoscopy | Device | MCE |
| Standard gastroscopy | Device | Standard gastroscopy |
Primary outcome
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy
Time frame: 2 days
Number of gastric focal lesions founded by MCE Versus Standard Gastroscopy
Time frame: 2 days
6 secondary outcomes
Volume of water and drugs used for gastric preparation
Time frame: 1 hour
Scores of the cleanliness of stomach after preparation
Time frame: 1 day
Percentage of patients in whom there was complete visualization of the gastric surface in the antrum, body, and fundus and identification of the cardia and pylorus
Time frame: 1 day
Examination times of MCE and standard gastroscopy
Time frame: 1 day
Patient acceptance of MCE 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 27211503Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
- Related InfoLink provided by the sponsor.
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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.
Zhaoshen Li, Prof. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MCE and Standard gastroscopy in people with Gastric Diseases, and Gastric Ulcer,, 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 3 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of subjects diagnosed with gastric diffuse lesions by MCE Versus Standard Gastroscopy (time frame: 2 days). The study lists 2 primary outcomes in all. 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 NCT02219529, 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.