OutpatientsNCT03457909
Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach
A study testing DS-MCE in people with Outpatients, run by Changhai Hospital at 1 site in China.
Trial summary
The purpose of the study is to determine the safety and feasibility of the new technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating gastric and esophagus diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Outpatients
- 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
- 7 Mar 2018to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- outpatients who have esophagus symptoms.
Who cannot join
- known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
- dysphagia or delayed gastric emptying.
- known or suspected possibility of active bleeding of digestive tract.
- a history of abdominal operation.
- pacemaker implantation and gastrointestinal pacemaker users.
- patients who are allergic to simethicone or pronase.
- pregnant women,mental patients.
- other circumstances that doctors consider inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach
The purpose of the study is to determine the safety and feasibility of the new technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating gastric and esophagus diseases.
Read the detailed description
Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string.
This study is a prospective, single-centered, self-controlled pilot study.Outpatients who have esophagus symptoms will take conventional endoscopy examination and DS-MCE successively.
- Conditions
- Outpatients
- Being tested
- DS-MCE
- Keywords
- string, capsule endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-MCEDevice
During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
| Study group | Role | What they receive |
|---|---|---|
| DS-MCE | Experimental | outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively. Receives: Device: DS-MCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
evaluate the feasibility of the novel DS-MCE examination. The successful separation of the capsule and string was evaluated by the capsule entering the stomach and and the string being pulled out.Complete viewing of esophagus and stomach was evaluated by completing the procedure from the capsule being swallowed, the esophagus observed retrograde, to the string being pulled out after separating from the capsule.This primary outcome indicated how many participatns completed the DS-MCE examination successfully.
Measured: up to 2 weeks
Secondary outcomes (5)
Number of DS-MCE Associated Adverse Events
evaluate the safety of DS-MCE.Record any adverse event during the procedure and after the procedure.Patients will be followed up by telephone to inquire about the symptoms of abdominal distention, abdominal pain,vomiting and other discomfort. Follow up to the end of the capsule expulsion.
Measured: up to 2 weeks
Duration of Time Capsule is Within the Esophagus
time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach
Measured: up to 2 weeks
Z-line Visualization
Z-line represents the normal esophagogastric junction where the squamous mucosa of the esophagus and columnar mucosa of the stomach meet.We can devide the Z-line into four quadrants under capsule endoscopy. Observing all the four quadrants is considered to be a complete observation of Z-line. In this study,the number of participants with at least two quadrants of Z-line visualized was used to evaluate the Z-line visulization.
Measured: up to 2 weeks
Quality Score of Z-line Images
grade (mild, moderate,and severe) of air-bubble and saliva interference on the Z-line view(0, no intraluminal gas bubble; 1, a few gas bubbles, no limitation of interpretation; 2, an increased amount of intraluminal foam/gas bubbles, moderate limitation of visibility; 3, an amount of foam/gas bubbles)
Measured: up to 2 weeks
Degree of Comfort
evaluate patient's degree of comfort throughout the procedure.Patients will be asked to fill in a questionnaire to give scores about degree of comfort throughout the procedure.Overall discomfort was scored on a scale of 0 to 10 (0, no discomfort; 10, the overall discomfort of EGD).
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 posted8 Mar 2018
- Study start7 Mar 2018
- Primary completion10 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OutpatientsStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, Study chair, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457909
- Sponsor's protocol ID
- DS-MCE-esophagus and stomach
- Status last verified
- Aug 2019
- First submitted
- 4 Feb 2018
- Last updated
- 23 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach
- ClinicalTrials.gov ID
- NCT03457909
- Acronym / sponsor ID
- DS-MCE-esophagus and stomach
- Conditions
- Outpatients
- Keywords
- string, capsule endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Posted 23 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the safety and feasibility of the new technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating gastric and esophagus diseases.
Detailed description
Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string.
This study is a prospective, single-centered, self-controlled pilot study.Outpatients who have esophagus symptoms will take conventional endoscopy examination and DS-MCE 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 | Experimental | Device: DS-MCEoutpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- outpatients who have esophagus symptoms.
Key exclusion criteria (8 listed)
- known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.
- dysphagia or delayed gastric emptying.
- known or suspected possibility of active bleeding of digestive tract.
- a history of abdominal operation.
- pacemaker implantation and gastrointestinal pacemaker users.
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-MCEDuring the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely. | Device | DS-MCE |
Primary outcome
Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
Time frame: up to 2 weeks
evaluate the feasibility of the novel DS-MCE examination. The successful separation of the capsule and string was evaluated by the capsule entering the stomach and and the string being pulled out.Complete viewing of esophagus and stomach was evaluated by completing the procedure from the capsule being swallowed, the esophagus observed retrograde, to the string being pulled out after separating from the capsule.This primary outcome indicated how many participatns completed the DS-MCE examination successfully.
5 secondary outcomes
Number of DS-MCE Associated Adverse Events
Time frame: up to 2 weeks
Duration of Time Capsule is Within the Esophagus
Time frame: up to 2 weeks
Z-line Visualization
Time frame: up to 2 weeks
Quality Score of Z-line Images
Time frame: up to 2 weeks
Degree of Comfort
Time frame: up to 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 chair
Changhai Hospital
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 Outpatients, 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 1 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 23 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach (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?
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 23 Sep 2019.