Capsule EndoscopyNCT06020859
MCE-new for Detection of Gastric Lesions
A study testing undergo NaviEC-2000Pro Gastro Scan mode, NaviEC-2000Pro Routine gastric examination and NaviEC-1000 Routine gastric examination in people with Capsule Endoscopy, run by Changhai Hospital.
Trial summary
Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Capsule Endoscopy
- What is being tested?
- undergo NaviEC-2000Pro Gastro Scan mode, NaviEC-2000Pro Routine gastric examination and NaviEC-1000 Routine gastric examination
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 30 Nov 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- underwent gastric examination;
- At least 18 years old；
- Be able to provide informed consent.
Who cannot join
- With swallowing obstruction or disorders;
- With known or suspected gastrointestinal obstruction, stenosis and fistula;
- Have no conditions for surgery or refuse to undergo any abdominal surgery;
- Be allergic to or have other known contraindication or intolerance to the drug used in the study;
- With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
- Women during pregnancy;
- Currently enrolled in another clinical trial of a drug or device;
- Other conditions determined by the investigator to be inappropriate for enrollment.
Trial locations and contacts
No sites are listed yet.
Yangyang Qian contact
About this study
Official title: New MCE System for Detection of Gastric Lesions
Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial
Read the detailed description
The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.
- Conditions
- Capsule Endoscopy
- Being tested
- undergo NaviEC-2000Pro Gastro Scan mode, NaviEC-2000Pro Routine gastric examination, NaviEC-1000 Routine gastric examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
undergo NaviEC-2000Pro Gastro Scan modeDevice
Patients undergo NaviEC-2000Pro Gastro Scan mode.
NaviEC-2000Pro Routine gastric examinationDevice
Patients undergo NaviEC-2000Pro Routine gastric examination mode.
NaviEC-1000 Routine gastric examinationDevice
Patients undergo NaviEC-1000 Routine gastric examination mode.
| Study group | Role | What they receive |
|---|---|---|
| NaviEC-2000Pro Gastro Scan | Experimental | NaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro Receives: Device: undergo NaviEC-2000Pro Gastro Scan mode |
| NaviEC-2000Pro Routine gastric examination | Experimental | NaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro Receives: Device: NaviEC-2000Pro Routine gastric examination |
| NaviEC-1000 Routine gastric examination | Active comparator | NaviEC-1000 Routine gastric examination is a mode of NaviEC-1000 Receives: Device: NaviEC-1000 Routine gastric examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
the degree of gastric mucosal visualization
The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, <70% of the gastric mucosa can be observed.
Measured: 2 weeks
Secondary outcomes (4)
The time of gastric examination
The total time MCE required to complete the stomach examination
Measured: 2 weeks
detection of lesions
The detection of gastric lesions by MCE
Measured: 2 weeks
Equipment operation evaluation
Operation fluency is defined as the smooth response between operation and real-time capsule shooting. Stability is defined as the stable ability to control the capsule in a fixed position; Comfort is defined as the operator's operating comfort during examination. They were all rated on a scale of 1-5, with 1 being the worst and 5 the best
Measured: 2 weeks
Safety Assessment
Number and incidence of device-related adverse events and serious adverse events
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 posted1 Sep 2023
- Study start30 Aug 2023 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Capsule EndoscopyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020859
- Sponsor's protocol ID
- MCE-new
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.
PubMed 30005825Liao 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New MCE System for Detection of Gastric Lesions
- ClinicalTrials.gov ID
- NCT06020859
- Acronym / sponsor ID
- MCE-new
- Conditions
- Capsule Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 1 Sep 2023 (actual)
- 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.
Clinical application of magnetically controlled capsule endoscopy : a prospective self-controlled trial
Detailed description
The aim of this study is to investigate the effectiveness and safety of using a new MCE system for routine gastric examination and automatic scanning. This study is a prospective, self controlled clinical trail, which includes adult patients who plan to undergo MCE examination. Patients will undergo three different tests during the experiment: NaviEC-2000Pro Gastro Scan, NaviEC-2000Pro routine gastric examination, NaviEC-1000 routine gastric examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NaviEC-2000Pro Gastro Scan | Experimental | Device: undergo NaviEC-2000Pro Gastro Scan modeNaviEC-2000Pro Gastro Scan is a new mode of NaviEC-2000Pro |
| NaviEC-2000Pro Routine gastric examination | Experimental | Device: NaviEC-2000Pro Routine gastric examinationNaviEC-2000Pro Routine gastric examination is a mode of NaviEC-2000Pro |
| NaviEC-1000 Routine gastric examination | Active comparator | Device: NaviEC-1000 Routine gastric examinationNaviEC-1000 Routine gastric examination is a mode of NaviEC-1000 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- underwent gastric examination;
- At least 18 years old；
- Be able to provide informed consent.
Key exclusion criteria (8 listed)
- With swallowing obstruction or disorders;
- With known or suspected gastrointestinal obstruction, stenosis and fistula;
- Have no conditions for surgery or refuse to undergo any abdominal surgery;
- Be allergic to or have other known contraindication or intolerance to the drug used in the study;
- With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies;
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 |
|---|---|---|
| undergo NaviEC-2000Pro Gastro Scan modePatients undergo NaviEC-2000Pro Gastro Scan mode. | Device | NaviEC-2000Pro Gastro Scan |
| NaviEC-2000Pro Routine gastric examinationPatients undergo NaviEC-2000Pro Routine gastric examination mode. | Device | NaviEC-2000Pro Routine gastric examination |
| NaviEC-1000 Routine gastric examinationPatients undergo NaviEC-1000 Routine gastric examination mode. | Device | NaviEC-1000 Routine gastric examination |
Primary outcome
the degree of gastric mucosal visualization
Time frame: 2 weeks
The overall observational integrity of the gastric mucosa is based on the evaluation of the mucosal visualization of several key anatomical sites in the stomach: cardia, fundus, gastric body, gastric horn, gastric antrum and pylorus. The evaluation criteria for mucosal visualization of each site are: good : adequate observation, ≥90% of the gastric mucosa can be observed; fair : good observation, 70-90% of the gastric mucosa can be observed; poor : inadequate observation, <70% of the gastric mucosa can be observed.
4 secondary outcomes
The time of gastric examination
Time frame: 2 weeks
detection of lesions
Time frame: 2 weeks
Equipment operation evaluation
Time frame: 2 weeks
Safety Assessment
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Background: PubMed 30005825Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.
- Background: 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.
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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.
Yangyang Qian contact
Questions about this trial
What is this clinical trial studying?
A study testing undergo NaviEC-2000Pro Gastro Scan mode, NaviEC-2000Pro Routine gastric examination and NaviEC-1000 Routine gastric examination in people with Capsule Endoscopy, run by Changhai Hospital.
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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuan Liao (86-21-31161004, liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the degree of gastric mucosal visualization (time frame: 2 weeks). 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 NCT06020859, which also lists 2 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 1 Sep 2023.