N/A N=40 Randomized Prevention

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

Gastrointestinal Disease · Infectious Disease · Capsule Endoscopy

Bottom Line

View on ClinicalTrials.gov: NCT04389333 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2022

Primary outcome: Primary: Number of Participants With Complete Observation — 20; 20 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: non-contact magnetically-controlled capsule endoscopy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Changhai Hospital
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete Observation	20; 20	—
SECONDARY Maneuverability Score	4.5; 5; 5; 5; 5; 5	—
SECONDARY Gastric Examination Time(GET)	12.3; 7.2	—
SECONDARY the Comfort and Acceptability of Patients	9; 9; 45; 44	—
SECONDARY The Total Number of Patients Who Who Had a Diagnosis of Positive Findings	2; 3; 2; 1; 0; 2	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04389333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.