NCT03457909

Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach

Completed NA Results posted Last updated 23 September 2019

What this trial tests

NA trial testing DS-MCE in Outpatients in 25 participants. Completed in 1 August 2018.

Timeline

7 March 2018

Primary endpoint
10 July 2018

1 August 2018

Quick facts

Lead sponsor	Changhai Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	25
Start date	7 March 2018
Primary completion	10 July 2018
Estimated completion	1 August 2018
Sites	1 location across China

Drugs / interventions tested

• DS-MCE

Conditions studied

• Outpatients — all drugs for Outpatients →

Sponsor

Changhai Hospital

Who can join

Adults 18 to 75, any sex, with Outpatients. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach Primary · up to 2 weeks

evaluate the feasibility of the novel DS-MCE examination. The successful separation of the capsule and string was evaluated by the capsule entering the stomach and and the string being pulled out.Complete viewing of esophagus and stomach was evaluated by completing the procedure from the capsule being swallowed, the esophagus observed retrograde, to the string being pulled out after separating from the capsule.This primary outcome indicated how many participatns completed the DS-MCE examination successfully.

Group	Value	95% CI
DS-MCE	25

Number of DS-MCE Associated Adverse Events Secondary · up to 2 weeks

evaluate the safety of DS-MCE.Record any adverse event during the procedure and after the procedure.Patients will be followed up by telephone to inquire about the symptoms of abdominal distention, abdominal pain,vomiting and other discomfort. Follow up to the end of the capsule expulsion.

Group	Value	95% CI
DS-MCE	0

Duration of Time Capsule is Within the Esophagus Secondary · up to 2 weeks

time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach

Group	Value	95% CI
DS-MCE	6.2	2.2 – 22.2

Z-line Visualization Secondary · up to 2 weeks

Z-line represents the normal esophagogastric junction where the squamous mucosa of the esophagus and columnar mucosa of the stomach meet.We can devide the Z-line into four quadrants under capsule endoscopy. Observing all the four quadrants is considered to be a complete observation of Z-line. In this study,the number of participants with at least two quadrants of Z-line visualized was used to evaluate the Z-line visulization.

Group	Value	95% CI
DS-MCE	20

Quality Score of Z-line Images Secondary · up to 2 weeks

grade (mild, moderate,and severe) of air-bubble and saliva interference on the Z-line view(0, no intraluminal gas bubble; 1, a few gas bubbles, no limitation of interpretation; 2, an increased amount of intraluminal foam/gas bubbles, moderate limitation of visibility; 3, an amount of foam/gas bubbles)

Group	Value	95% CI
DS-MCE	0.68	0 – 1

Degree of Comfort Secondary · up to 2 weeks

evaluate patient's degree of comfort throughout the procedure.Patients will be asked to fill in a questionnaire to give scores about degree of comfort throughout the procedure.Overall discomfort was scored on a scale of 0 to 10 (0, no discomfort; 10, the overall discomfort of EGD).

Group	Value	95% CI
DS-MCE	0.96	0 – 3

Sponsor's own description

The purpose of the study is to determine the safety and feasibility of the new technique,detachable string magnetically controlled capsule endoscopy(DS-MCE)for evaluating gastric and esophagus diseases.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.