Capsule Endoscopy, Gastrointestinal Disease, Infectious Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEnon-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.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Observation | During the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maneuverability Score | During the procedure | 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. |
| Gastric Examination Time(GET) | During the procedure | GET was defined as the time taken for the endoscopist to complete the gastric examination to his or her satisfaction |
| the Comfort and Acceptability of Patients | After the procedure(within 5 days) | 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. |
| The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | after the procedure(within 5 days) | It was calculated using the following formula: number of patients with positive findings divided by the total number of patients that underwent examination. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | During and within 2 weeks after the procedure | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | ncMCE Group | MCE Group |
|---|---|---|---|
| Age, Continuous | 49.8 years STANDARD_DEVIATION 12.72 | 46.1 years STANDARD_DEVIATION 14.8 | 53.5 years STANDARD_DEVIATION 9.2 |
| Diabetes | 3 Participants | 2 Participants | 1 Participants |
| Drinking history | 13 Participants | 6 Participants | 7 Participants |
| History of abdominal surgery | 10 Participants | 4 Participants | 6 Participants |
| Indication:Abdominal distension | 13 Participants | 7 Participants | 6 Participants |
| Indication:Abdominal pain | 12 Participants | 9 Participants | 3 Participants |
| Indication: Acid reflux | 2 Participants | 0 Participants | 2 Participants |
| Indication:Health checkup | 8 Participants | 2 Participants | 6 Participants |
| Indication: Others | 3 Participants | 0 Participants | 3 Participants |
| Indication:Symptoms | 32 Participants | 18 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 40 Participants | 20 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Male | 19 Participants | 11 Participants | 8 Participants |
| Smoking history | 9 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: During the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ncMCE Group | Number of Participants With Complete Observation | 20 Participants |
| MCE Group | Number of Participants With Complete Observation | 20 Participants |
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
Time frame: During the procedure
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ncMCE Group | Gastric Examination Time(GET) | 12.3 minute |
| MCE Group | Gastric Examination Time(GET) | 7.2 minute |
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.
Time frame: During the procedure
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ncMCE Group | Maneuverability Score | Comfortableness | 5 score on a scale |
| ncMCE Group | Maneuverability Score | Compliance of patients | 5 score on a scale |
| ncMCE Group | Maneuverability Score | Visualization | 5 score on a scale |
| ncMCE Group | Maneuverability Score | Total | 19.25 score on a scale |
| ncMCE Group | Maneuverability Score | Transmission quality | 4.5 score on a scale |
| MCE Group | Maneuverability Score | Total | 20 score on a scale |
| MCE Group | Maneuverability Score | Transmission quality | 5 score on a scale |
| MCE Group | Maneuverability Score | Comfortableness | 5 score on a scale |
| MCE Group | Maneuverability Score | Visualization | 5 score on a scale |
| MCE Group | Maneuverability Score | Compliance of patients | 5 score on a scale |
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.
Time frame: After the procedure(within 5 days)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| ncMCE Group | the Comfort and Acceptability of Patients | Pre-procedure patient perception | 9 score on a scale |
| ncMCE Group | the Comfort and Acceptability of Patients | Post-procedure patient satisfaction | 45 score on a scale |
| MCE Group | the Comfort and Acceptability of Patients | Pre-procedure patient perception | 9 score on a scale |
| MCE Group | the Comfort and Acceptability of Patients | Post-procedure patient satisfaction | 44 score on a scale |
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.
Time frame: after the procedure(within 5 days)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ncMCE Group | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | Polyp | 2 Participants |
| ncMCE Group | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | Erosion | 2 Participants |
| ncMCE Group | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | Ulcer | 0 Participants |
| ncMCE Group | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | Total | 4 Participants |
| MCE Group | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | Total | 6 Participants |
| MCE Group | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | Polyp | 3 Participants |
| MCE Group | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | Ulcer | 2 Participants |
| MCE Group | The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | Erosion | 1 Participants |
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.
Time frame: During and within 2 weeks after the procedure
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ncMCE Group | Adverse Events | 0 Participants |
| MCE Group | Adverse Events | 0 Participants |