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In December 2019, an outbreak of pneumonia associated with a novel coronavirus named as severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) was reported in Wuhan city, China, and spread exponentially throughout China and other countries in the following weeks.
It is recommended that elective endoscopies should be deferred during the COVID-19 outbreak for the potential transmission between patients and medical staff in the statements of Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Therefore, exploring an alternative for patients with the requirements of endoscopy during the outbreak is of great importance.
Herein,the investigators developed an novel non-contact magnetically-controlled capsule endoscopy (Nc-MCE) system (Figure 1) adds a remote control workstation and a audio-visual exchange system to the original well-established MCE system.
This study was a open-label, prospective, randomized controlled study approved by the institutional review board of Shanghai Changhai Hospital. It was designed to evaluate the diagnostic utility, safety, feasibility and patients acceptability of Nc-MCE in patients with an indication of endoscopy, and comparing it with the result of MCE.
The nc-MCE system added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system.Conventional protective measures could be adopted to endoscopist. Although the endoscopist and the patient are in different rooms, the endoscopist was able to see the patient and communicate with him or her through the audio-visual exchange system all the time. In order to simplify the examination procedure, the data recorder was putted on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist.And the endoscopist of MCE and nc-MCE was the same one with experience of more than 1000 cases of MCCG operation.
The investigators recruited 40 patients who have related symptom and healthy people mainly from outpatient clinic or hospital health examination center. After fully understanding the procedure of nc-MCE, patients with informed consent were randomly divided into MCE group and nc-MCE group(1:1) by using a stratified block randomization(block size four).
The basic characteristics of the enrolled patients were prospectively collected. The primary endpoint was the maneuverability score evaluated by endoscopist. And the investigators choose the gastric examination time,the comfort and acceptability of patients, diagnostic yield and completeness of gastric examination as the secondary endpoint. The safety endpoint of nc-MCE was evaluated by the occurrence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-contact MCE examination | Experimental | After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the study subject positions himself (herself) on the examination bed in Room A, while the operating doctor sits in Room B at the remote control workstation instructing her to swallow the capsule via the audio-visual exchange system. After the capsule entering the stomach, the doctor manipulated the two joysticks on the remote control workstation, mobilizing the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric examination. In order to simplify the examination procedure, the data recorder was put on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist. |
|
| MCE examination | Active Comparator | After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the subjects put on the data recorder with the help of an endoscopist. Then, the endoscopist activated the capsule with the capsule locator. The patient was instructed to assume the supine or left lateral decubitus position and to swallow the capsule with a small amount of water to effectively observe the esophagus and dentate line. Then, under the guidance of the endoscopist face to face, the subject turned over on the bed to complete the examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-contact magnetically-controlled capsule endoscopy | Device | The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Observation | The number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Maneuverability Score | Maneuverability score was the sum of four subjective scores rated by the operator (signal transmission quality score, operating comfort score, gastric visualization score and study subject compliance score), each of which ranged from 1 to 5 denoting the lowest to the highest degree of satisfaction and the range of total score from 0 to 20. The higher the score, the better the maneuverability. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Each patient was followed up for 2 weeks by telephone and hospital information system to confirm capsule excretion and any adverse events (AEs), including COVID-19 infection. | During and within 2 weeks after the procedure |
Inclusion Criteria:
Signed the informed consents before joining this study
Exclusion Criteria:
(1) dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis,overt gastrointestinal bleeding,fistulas and strictures; (2)history of upper gastrointestinal surgery or suspected delayed gastric emptying; (3) Patients with poor general condition,asthma or claus trophobia; (4) Implanted metallic devices such as pacemakers,defibrillators, artificial heart valves or joint prostheses; (5) Pregnancy or mentally ill person; (6) currently participating in another clinical study;(7)communication obstacles persons.
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| Name | Affiliation | Role |
|---|---|---|
| Zhuan Liao, MD | Department of Gastroenterology, Changhai Hospital, the Naval Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30822803 | Background | 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. | |
| 31194028 | Background | Jiang X, Pan J, Li ZS, Liao Z. Standardized examination procedure of magnetically controlled capsule endoscopy. VideoGIE. 2019 May 30;4(6):239-243. doi: 10.1016/j.vgie.2019.03.003. eCollection 2019 Jun. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-contact MCE Examination | After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the study subject positions himself (herself) on the examination bed in Room A, while the operating doctor sits in Room B at the remote control workstation instructing her to swallow the capsule via the audio-visual exchange system. After the capsule entering the stomach, the doctor manipulated the two joysticks on the remote control workstation, mobilizing the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric examination. In order to simplify the examination procedure, the data recorder was put on the examination bed. The patient lay down after swallowing the capsule under the remote guidance of the endoscopist. non-contact magnetically-controlled capsule endoscopy: The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope. |
| FG001 | MCE Examination | After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the subjects put on the data recorder with the help of an endoscopist. Then, the endoscopist activated the capsule with the capsule locator. The patient was instructed to assume the supine or left lateral decubitus position and to swallow the capsule with a small amount of water to effectively observe the esophagus and dentate line. Then, under the guidance of the endoscopist face to face, the subject turned over on the bed to complete the examination. non-contact magnetically-controlled capsule endoscopy: The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
From March 26, 2020 to April 26, 2020, 40 patients (19 men and 21 women) were enrolled and included in the analysis. Of them, 20 accepted MCE and 20 underwent ncMCE according to the random number table.
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| ID | Title | Description |
|---|---|---|
| BG000 | ncMCE Group | The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center [10]. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 Complete Observation | The number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus. | Posted | Count of Participants | Participants | During the procedure |
|
safety based on the occurrence of adverse events (AEs) including infection which was recorded till the 14 days after swallowing the capsule.
Each patient was followed up for 2 weeks by telephone and hospital information system to confirm capsule excretion and any adverse events (AEs), Possible adverse events included capsule retention, dysphagia, capsule incarceration, infection of SARS-COV-2.
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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 | ncMCE Group | The ncMCE system adds a remote control workstation and an audio-visual exchange system to the original well-established MCE system, which was developed and tested at our medical center. To simplify the preparation process, we embedded the data recorder in the examination bed. The ncMCE system separates endoscopists and patients in two rooms (control room for the endoscopist and examination room for patients), offering physical isolation for noninvasive gastric examination during the pandemic. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zhuan Liao | National Clinical Research Center for Digestive Diseases Department of Gastroenterology | 21-31161004 | +86 | 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 3, 2020 | Dec 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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The investigators recruited 40 patients who have related symptom and healthy people mainly from outpatient clinic or hostipal health examination center. After fully understanding the procedure of nc-MCE，patients with informed consent were randomly divided into MCE group and nc-MCE group(1:1) by using a stratified block randomization(block size four)
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|
| During the procedure |
| Gastric Examination Time(GET) | GET was defined as the time taken for the endoscopist to complete the gastric examination to his or her satisfaction | During the procedure |
| the Comfort and Acceptability of Patients | The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient by two sub questionnaires, which was pre-procedure patient perception (3 items, ranged from 0 to 12 ) and post-procedure patient satisfaction (12 items, ranged from 0 to 48) .The higher the score, the worse the patient's satisfaction. | After the procedure(within 5 days) |
| The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | It was calculated using the following formula: number of patients with positive findings divided by the total number of patients that underwent examination. | after the procedure(within 5 days) |
| 32241897 | Background | Chiu PWY, Ng SC, Inoue H, Reddy DN, Ling Hu E, Cho JY, Ho LK, Hewett DG, Chiu HM, Rerknimitr R, Wang HP, Ho SH, Seo DW, Goh KL, Tajiri H, Kitano S, Chan FKL. Practice of endoscopy during COVID-19 pandemic: position statements of the Asian Pacific Society for Digestive Endoscopy (APSDE-COVID statements). Gut. 2020 Jun;69(6):991-996. doi: 10.1136/gutjnl-2020-321185. Epub 2020 Apr 2. |
| 27965879 | Background | Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016. |
| 31981648 | Background | Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22. |
| BG001 | MCE Group | The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| History of abdominal surgery | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| Drinking history | Count of Participants | Participants |
|
| Indication:Symptoms | Count of Participants | Participants |
|
| Indication:Health checkup | Count of Participants | Participants |
|
| Indication:Abdominal pain | Count of Participants | Participants |
|
| Indication:Abdominal distension | Count of Participants | Participants |
|
| Indication: Acid reflux | Count of Participants | Participants |
|
| Indication: Others | The other indications included other inspection reasons except for abdominal pain, abdominal distension, acid reflux and health checkup. | Count of Participants | Participants |
|
| MCE Group |
The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides. |
|
|
| Secondary | Maneuverability Score | Maneuverability score was the sum of four subjective scores rated by the operator (signal transmission quality score, operating comfort score, gastric visualization score and study subject compliance score), each of which ranged from 1 to 5 denoting the lowest to the highest degree of satisfaction and the range of total score from 0 to 20. The higher the score, the better the maneuverability. | Posted | Median | Inter-Quartile Range | score on a scale | During the procedure |
|
|
|
| Secondary | Gastric Examination Time(GET) | GET was defined as the time taken for the endoscopist to complete the gastric examination to his or her satisfaction | Posted | Mean | Inter-Quartile Range | minute | During the procedure |
|
|
|
| Secondary | the Comfort and Acceptability of Patients | The investigators use a satisfaction questionnaire to evaluate the comfort and acceptability of each patient by two sub questionnaires, which was pre-procedure patient perception (3 items, ranged from 0 to 12 ) and post-procedure patient satisfaction (12 items, ranged from 0 to 48) .The higher the score, the worse the patient's satisfaction. | Posted | Median | Inter-Quartile Range | score on a scale | After the procedure(within 5 days) |
|
|
|
| Secondary | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | It was calculated using the following formula: number of patients with positive findings divided by the total number of patients that underwent examination. | Posted | Count of Participants | Participants | after the procedure(within 5 days) |
|
|
|
| Other Pre-specified | Adverse Events | Each patient was followed up for 2 weeks by telephone and hospital information system to confirm capsule excretion and any adverse events (AEs), including COVID-19 infection. | Each patient was followed up for 2 weeks by telephone and hospital information system to confirm capsule excretion and any adverse events (AEs), including COVID-19 infection. | Posted | Count of Participants | Participants | During and within 2 weeks after the procedure |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | MCE Group | The MCE system (Ankon Technologies Co., Ltd. Shanghai, China) consists of a guidance C-arm magnet robot, a computer workstation with ESNavi software, endoscopic capsule, capsule locator, and a vest-like data recorder that can receive capsule signals from both sides. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |
| Visualization |
|
| Compliance of patients |
|
| Total |
|
| Ulcer |
|
| Total |
|