Capsule EndoscopyNCT04329468
Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel
A study testing DS-MCE in people with Capsule Endoscopy, run by Zhuan Liao at 1 site in China.
Trial summary
This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD. 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?
- DS-MCE
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2020to 20 Sep 2020
- 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
- Adult patients aged 18 to 80
- With or without gastrointestinal complaints
- Scheduled to undergo a capsule endoscopy for both stomach and small bowel
- Signed the informed consents before joining this study
Who cannot join
- Pacemakers or electromedical devices implanted which are incompatible with magnetic field;
- Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention;
- Scheduled magnetic resonance imaging examination before excretion of capsule;
- Pregnancy or suspected pregnancy;
- Any contraindications about EGD.
- Other circumstances that doctors consider inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, 200433
Zhuan Liao, 86-21-31161004, liaozhuan@smmu.edu.cn
Bin Jiang
About this study
Official title: Detachable String Magnetically Controlled Capsule Endoscopy for Complete Examination of Upper Gastrointestinal Tract and Small Bowel
This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.
Read the detailed description
Magnetically controlled capsule endoscopy (MCE) has been widely used in clinical practice for upper gastrointestinal (UGI) tract and Small Bowel. However, the complete visualization of UGI tract still present challenges due to rapid transit through esophagus and duodenum, although technical improvements of MCE are helpful.
Detachable String MCE (DS-MCE) can control the movement of MCE through the string and MCE can start next examination after string detachment, which was proved to be an effective and safe method for complete viewing of the esophagus and stomach. In order to improve the duodenum visualization, endoscopist separate MCE from the string after finishing UGI examination so that can inspect the esophagus, stomach and duodenum under the string and magnetic field control.
This is a prospective, single-centered, self-controlled pilot study. Subjects with or without digestive symptoms receiving UGI endoscopy will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.
- Conditions
- Capsule Endoscopy
- Being tested
- DS-MCE
- Keywords
- DS-MCE, Z-line, Duodenal papilla, Completion rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-MCEDevice
The subjects swallowed the MCE to investigate the esophagus repeatedly by pulling up or down the string. After completion of the esophageal examination, MCE reached the stomach and was lifted away from the posterior wall, rotated if necessary and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination, the capsule would enter the duodenum due to peristalsis when the pylorus opened. Then DS-MCE tried to inspect the duodenum repeatedly under the string and magnetic field control, including view of major papilla in the descending part of duodenum and retrograde view of pylorus in duodenal bulb with a "360-degree automatic scanning" mode. After completion of the duodenum examination, the capsule started to view the small bowel.
| Study group | Role | What they receive |
|---|---|---|
| DS-MCE examination | Experimental | Subjects with or without digestive symptoms will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively. Receives: Device: DS-MCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of UGI and small-bowel examination
The feasibility of DS-MCE examination with a novel way is evaluated by the technical success rate, a composite outcome including the successful separation of the string and MCE, repeat viewing of esophagus, stomach and duodenum, and complete small-bowel examination.
Measured: up to 2 weeks
Secondary outcomes (11)
Diagnostic accuracy
The diagnostic accordance rate, sensitivity and specificity of lesions detected by DS-MCE compared with EGD.
Measured: up to 2 weeks
Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded
The presence of any adverse events during DS-MCE procedure will be recorded.
Measured: up to 2 weeks
Detection rate of Z-line, duodenal papilla and pyloric retrograde view
The detection means that at least one image of anatomical structure was obtained.
Measured: up to 2 weeks
Circumferential visualization of the Z-line and duodenal papilla
It is defined by quadrants as follows: less than 2 quadrants (< 50%) observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire structure (100%) observed.
Measured: up to 2 weeks
Cleansing level of Z-line and duodenal papilla area
The effect of bubbles/saliva on the appearance of the Z line or duodenal papilla area was both scored as follows: 0=no interference by bubbles/saliva;1=minor interference of bubbles/saliva; 2=major interference of bubbles/saliva.
Measured: up to 2 weeks
Visualization level of stomach
Visualization level of gastric primary anatomic landmarks: cardia, fundus, body, angulus, antrum and pylorus. (good, >75% of mucosa was observed; moderate, 50% to 75% was observed; poor, <50% of the gastric mucosa was observed)
Measured: up to 2 weeks
Examination time of esophagus, stomach, duodenum and small bowel
Record the time taken to finish examination in different digestive part.
Measured: up to 2 weeks
Pyloric transit time
Record the time from completion of the gastric examination to the capsule entering the duodenum.
Measured: up to 2 weeks
Discomfort scores associated with DS-MCE
Discomfort caused by the string, swallowing the DS-MCE, pulling the capsule up or down, and pulling the string out were on a scale from 0 to 3 (0=none;1=mild/minimal; 2=moderate; and 3=severe/very difficult) according to the Ramirez system. Overall discomfort was scored on a scale of 0 to 10 (0=no discomfort; 10=the overall discomfort of EGD) according to our previous system.
Measured: up to 2 weeks
Image quality scores
Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
Measured: up to 2 weeks
Detection rate of lesions
The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, jejunoileum) found by MCE.
Measured: up to 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 Apr 2020
- Study start10 Mar 2020
- Primary completion20 Aug 2020 (estimated)
- Study completion20 Sep 2020 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuan Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Study director, Changhai Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329468
- Sponsor's protocol ID
- DS-MCE-UGI and SB
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen YZ, Pan J, Luo YY, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach. Endoscopy. 2019 Apr;51(4):360-364. doi: 10.1055/a-0856-6845. Epub 2019 Mar 1.
PubMed 30822803Jiang B, Qian YY, Wang YC, Pan J, Jiang X, Zhu JH, Qiu XO, Zhou W, Li ZS, Liao Z. A novel capsule endoscopy for upper and mid-GI tract: the UMGI capsule. BMC Gastroenterol. 2023 Mar 16;23(1):76. doi: 10.1186/s12876-023-02696-5.
PubMed 36927462
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detachable String Magnetically Controlled Capsule Endoscopy for Complete Examination of Upper Gastrointestinal Tract and Small Bowel
- ClinicalTrials.gov ID
- NCT04329468
- Acronym / sponsor ID
- DS-MCE-UGI and SB
- Conditions
- Capsule Endoscopy
- Keywords
- DS-MCE, Z-line, Duodenal papilla, Completion rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Zhuan LiaoUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 20 Aug 2020 (estimated)
- Study completion
- 20 Sep 2020 (estimated)
- First posted
- 1 Apr 2020 (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.
This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.
Detailed description
Magnetically controlled capsule endoscopy (MCE) has been widely used in clinical practice for upper gastrointestinal (UGI) tract and Small Bowel. However, the complete visualization of UGI tract still present challenges due to rapid transit through esophagus and duodenum, although technical improvements of MCE are helpful.
Detachable String MCE (DS-MCE) can control the movement of MCE through the string and MCE can start next examination after string detachment, which was proved to be an effective and safe method for complete viewing of the esophagus and stomach. In order to improve the duodenum visualization, endoscopist separate MCE from the string after finishing UGI examination so that can inspect the esophagus, stomach and duodenum under the string and magnetic field control.
This is a prospective, single-centered, self-controlled pilot study. Subjects with or without digestive symptoms receiving UGI endoscopy will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DS-MCE examination | Experimental | Device: DS-MCESubjects with or without digestive symptoms will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 to 80
- With or without gastrointestinal complaints
- Scheduled to undergo a capsule endoscopy for both stomach and small bowel
- Signed the informed consents before joining this study
Key exclusion criteria (6 listed)
- Pacemakers or electromedical devices implanted which are incompatible with magnetic field;
- Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention;
- Scheduled magnetic resonance imaging examination before excretion of capsule;
- Pregnancy or suspected pregnancy;
- Any contraindications about EGD.
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 |
|---|---|---|
| DS-MCEThe subjects swallowed the MCE to investigate the esophagus repeatedly by pulling up or down the string. After completion of the esophageal examination, MCE reached the stomach and was lifted away from the posterior wall, rotated if necessary and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination, the capsule would enter the duodenum due to peristalsis when the pylorus opened. Then DS-MCE tried to inspect the duodenum repeatedly under the string and magnetic field control, including view of major papilla in the descending part of duodenum and retrograde view of pylorus in duodenal bulb with a "360-degree automatic scanning" mode. After completion of the duodenum examination, the capsule started to view the small bowel. | Device | DS-MCE examination |
Primary outcome
Success rate of UGI and small-bowel examination
Time frame: up to 2 weeks
The feasibility of DS-MCE examination with a novel way is evaluated by the technical success rate, a composite outcome including the successful separation of the string and MCE, repeat viewing of esophagus, stomach and duodenum, and complete small-bowel examination.
11 secondary outcomes
Diagnostic accuracy
Time frame: up to 2 weeks
Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded
Time frame: up to 2 weeks
Detection rate of Z-line, duodenal papilla and pyloric retrograde view
Time frame: up to 2 weeks
Circumferential visualization of the Z-line and duodenal papilla
Time frame: up to 2 weeks
Cleansing level of Z-line and duodenal papilla area
Time frame: up to 2 weeks
Visualization level of stomach
Time frame: up to 2 weeks
Examination time of esophagus, stomach, duodenum and small bowel
Time frame: up to 2 weeks
Pyloric transit time
Time frame: up to 2 weeks
Discomfort scores associated with DS-MCE
Time frame: up to 2 weeks
Image quality scores
Time frame: up to 2 weeks
Detection rate of lesions
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Background: PubMed 30822803Chen YZ, Pan J, Luo YY, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach. Endoscopy. 2019 Apr;51(4):360-364. doi: 10.1055/a-0856-6845. Epub 2019 Mar 1.
- Derived from this study: PubMed 36927462Jiang B, Qian YY, Wang YC, Pan J, Jiang X, Zhu JH, Qiu XO, Zhou W, Li ZS, Liao Z. A novel capsule endoscopy for upper and mid-GI tract: the UMGI capsule. BMC Gastroenterol. 2023 Mar 16;23(1):76. doi: 10.1186/s12876-023-02696-5.
- Individual participant dataSharing planned: No
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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.
Zhuan Liao study director
Changhai Hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DS-MCE in people with Capsule Endoscopy, run by Zhuan Liao 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 4 inclusion and 6 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 21 Jul 2020. 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.
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 Bin Jiang (15021569528 ext. 15021569528, jarz1995@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of UGI and small-bowel examination (time frame: up to 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 NCT04329468, 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 21 Jul 2020.