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Completed

NCT Number: NCT04389333

Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic

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.

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Key information

Conditions

Gastrointestinal Disease Capsule Endoscopy Communicable Diseases Digestive System Diseases Disease Attributes Gastrointestinal Diseases Infections Infectious Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Complete Observation

    Time frame: 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 outcomes

  1. Maneuverability Score

    Time frame: 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.

  2. Gastric Examination Time(GET)

    Time frame: During the procedure

    GET was defined as the time taken for the endoscopist to complete the gastric examination to his or her satisfaction

  3. the Comfort and Acceptability of Patients

    Time frame: 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.

  4. The Total Number of Patients Who Who Had a Diagnosis of Positive Findings

    Time frame: 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 outcomes

  1. Adverse Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Feasibility of Non-contact Magnetically-controlled Capsule Endoscopy During COVID-19 Pandemic: a Prospective, Open-label, Pilot, Randomized Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 15, 2020
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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