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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-MCE | Experimental | outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-MCE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhuan Liao | Changhai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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This study was a prospective, self-controlled, single-centered pilot study. After enrollment, each enrolled subject first underwent DS-MCE(detachable string magnetically controlled capsule endoscopy), and subsequently EGD(esophagogastroduodenoscopy) within one week.
Healthy volunteers or patients with suspected esophageal diseases were prospectively enrolled in Changhai Hospital from March 2018 to June 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | DS-MCE | outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | DS-MCE | outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively. DS-MCE: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to 2 weeks |
|
All patients were followed up to 2 weeks to confirm capsule excretion and any adverse events.
strings and sleeves ruptured, capsule lost, asipration of the capsule，severe choking cough and death.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DS-MCE | outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Changhai Hospital | Department of Gastroenterology | 86-21-31161004 | 86-21-6549 | liaozhuan@smmu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2018 | Aug 21, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2018 | Aug 21, 2019 | SAP_001.pdf |
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| Duration of Time Capsule is Within the Esophagus | time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach | 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. | 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) | 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). | up to 2 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Posted | Number | adverse events | up to 2 weeks |
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| Secondary | Duration of Time Capsule is Within the Esophagus | time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach | Posted | Median | Full Range | minutes | up to 2 weeks |
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| Secondary | 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. | Posted | Number | participants | up to 2 weeks |
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| Secondary | 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) | Posted | Mean | Full Range | score on a scale | up to 2 weeks |
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| Secondary | 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). | Posted | Mean | Full Range | score on a scale | up to 2 weeks |
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| 25 |
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| 25 |
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