An interventional study of DS-MCE in Outpatients, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Other
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.
Exclusion Criteria:
outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.
Device: 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.
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.
Time frame: up to 2 weeks
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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: up to 2 weeks
Healthy volunteers or patients with suspected esophageal diseases were prospectively enrolled in Changhai Hospital from March 2018 to June 2018.
| Milestone | DS-MCE |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
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.
| Participants | DS-MCE |
|---|---|
| Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach | 25 |
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.
| adverse events | DS-MCE |
|---|---|
| Number of DS-MCE Associated Adverse Events | 0 |
time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach
| minutes | DS-MCE |
|---|---|
| Duration of Time Capsule is Within the Esophagus | 6.2 (2.2 to 22.2) |
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.
| participants | DS-MCE |
|---|---|
| Z-line Visualization | 20 |
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)
| score on a scale | DS-MCE |
|---|---|
| Quality Score of Z-line Images | 0.68 (0 to 1) |
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).
| score on a scale | DS-MCE |
|---|---|
| Degree of Comfort | 0.96 (0 to 3) |
Collected over All patients were followed up to 2 weeks to confirm capsule excretion and any adverse events.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DS-MCE | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | DS-MCE |
|---|---|
| Mean | 54 (28 to 72) |
| Sex: Female, Male(Participants) | DS-MCE |
|---|---|
| Female | 7 |
| Male | 18 |
| Race and Ethnicity Not Collected(Participants) | DS-MCE |
|---|
| Region of Enrollment(participants) | DS-MCE |
|---|---|
| China | 25 |
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Changhai Hospital