Outpatients
Conditions
Keywords
string, capsule endoscopy
Brief 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.
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.
Interventions
DEVICEDS-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.
Sponsors
Changhai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* outpatients who have esophagus symptoms.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of DS-MCE Associated Adverse Events | up to 2 weeks | 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. |
| Duration of Time Capsule is Within the Esophagus | up to 2 weeks | time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach |
| Z-line Visualization | up to 2 weeks | 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. |
| Quality Score of Z-line Images | up to 2 weeks | 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) |
| Degree of Comfort | up to 2 weeks | 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). |
Countries
China
Participant flow
Recruitment details
Healthy volunteers or patients with suspected esophageal diseases were prospectively enrolled in Changhai Hospital from March 2018 to June 2018.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | DS-MCE | — |
|---|---|---|
| Age, Continuous | 54 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 25 participants | — |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: up to 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DS-MCE | Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach | 25 Participants |
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).
Time frame: up to 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DS-MCE | Degree of Comfort | 0.96 score on a scale |
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
Time frame: up to 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DS-MCE | Duration of Time Capsule is Within the Esophagus | 6.2 minutes |
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.
Time frame: up to 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DS-MCE | Number of DS-MCE Associated Adverse Events | 0 adverse events |
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)
Time frame: up to 2 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DS-MCE | Quality Score of Z-line Images | 0.68 score on a scale |
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.
Time frame: up to 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DS-MCE | Z-line Visualization | 20 participants |