An interventional study of non-contact magnetically-controlled capsule endoscopy in Gastrointestinal Disease, Infectious Disease and Capsule Endoscopy, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Prevention
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.
639 studies on the registry are indexed under Gastrointestinal Diseases; 126 are open to participants now.
This study's enrollment of 40 is below the median of 77 across 428 interventional studies indexed under Gastrointestinal Diseases.
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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.
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.
Device: non-contact magnetically-controlled capsule endoscopy
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.
Device: 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.
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
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
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
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)
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)
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
| Milestone | Non-contact MCE Examination | MCE Examination |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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.
| Participants | ncMCE Group | MCE Group |
|---|---|---|
| Number of Participants With Complete Observation | 20 | 20 |
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.
| score on a scale | ncMCE Group | MCE Group |
|---|---|---|
| Transmission quality | 4.5 (4.5 to 5) | 5 (5 to 5) |
| Comfortableness | 5 (5 to 5) | 5 (5 to 5) |
| Visualization | 5 (5 to 5) | 5 (4 to 5) |
| Compliance of patients | 5 (5 to 5) | 5 (5 to 5) |
| Total | 19.25 (18.63 to 20) | 20 (19 to 20) |
GET was defined as the time taken for the endoscopist to complete the gastric examination to his or her satisfaction
| minute | ncMCE Group | MCE Group |
|---|---|---|
| Gastric Examination Time(GET) | 12.3 (7.5 to 16.3) | 7.2 (6.5 to 8.9) |
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.
| score on a scale | ncMCE Group | MCE Group |
|---|---|---|
| Pre-procedure patient perception | 9 (8 to 9) | 9 (8 to 9) |
| Post-procedure patient satisfaction | 45 (42.3 to 46.8) | 44 (42 to 45) |
It was calculated using the following formula: number of patients with positive findings divided by the total number of patients that underwent examination.
| Participants | ncMCE Group | MCE Group |
|---|---|---|
| Polyp | 2 | 3 |
| Erosion | 2 | 1 |
| Ulcer | 0 | 2 |
| Total | 4 | 6 |
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.
| Participants | ncMCE Group | MCE Group |
|---|---|---|
| Adverse Events | 0 | 0 |
Collected over safety based on the occurrence of adverse events (AEs) including infection which was recorded till the 14 days after swallowing the capsule.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ncMCE Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| MCE Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
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.
| Age, Continuous(years) | ncMCE Group | MCE Group | Total |
|---|---|---|---|
| Mean | 46.1 ± 14.8 | 53.5 ± 9.2 | 49.8 ± 12.72 |
| Sex: Female, Male(Participants) | ncMCE Group | MCE Group | Total |
|---|---|---|---|
| Female | 9 | 12 | 21 |
| Male | 11 | 8 | 19 |
| Race (NIH/OMB)(Participants) | ncMCE Group | MCE Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 20 | 20 | 40 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| History of abdominal surgery(Participants) | ncMCE Group | MCE Group | Total |
|---|---|---|---|
| Count of participants | 4 | 6 | 10 |
| Diabetes(Participants) | ncMCE Group | MCE Group | Total |
|---|---|---|---|
| Count of participants | 2 | 1 | 3 |
| Smoking history(Participants) | ncMCE Group | MCE Group | Total |
|---|---|---|---|
| Count of participants | 3 | 6 | 9 |
| Drinking history(Participants) | ncMCE Group | MCE Group | Total |
|---|---|---|---|
| Count of participants | 6 | 7 | 13 |
| Indication:Symptoms(Participants) | ncMCE Group | MCE Group | Total |
|---|---|---|---|
| Count of participants | 18 | 14 | 32 |
5 further baseline measures are reported on the registry.
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