Trial Outcomes & Findings for Detachable String Magnetically Controlled Capsule Endoscopy for Completely Viewing of Esophagus and Stomach (NCT NCT03457909)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

up to 2 weeks

Results posted on

2019-09-23

Participant Flow

Healthy volunteers or patients with suspected esophageal diseases were prospectively enrolled in Changhai Hospital from March 2018 to June 2018.

This study was a prospective, self-controlled, single-centered pilot study. After enrollment, each enrolled subject first underwent DS-MCE(detachable string magnetically controlled capsule endoscopy), and subsequently EGD(esophagogastroduodenoscopy) within one week.

Participant milestones

Participant milestones
Measure	DS-MCE outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DS-MCE n=25 Participants outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively. DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Age, Continuous	54 years n=25 Participants
Sex: Female, Male Female	7 Participants n=25 Participants
Sex: Female, Male Male	18 Participants n=25 Participants
Region of Enrollment China	25 participants n=25 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DS-MCE n=25 Participants outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach	25 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DS-MCE n=25 Participants outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Number of DS-MCE Associated Adverse Events	0 adverse events

SECONDARY outcome

Timeframe: up to 2 weeks

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

Outcome measures

Outcome measures
Measure	DS-MCE n=25 Participants outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Duration of Time Capsule is Within the Esophagus	6.2 minutes Interval 2.2 to 22.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DS-MCE n=25 Participants outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Z-line Visualization	20 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	DS-MCE n=25 Participants outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Quality Score of Z-line Images	0.68 score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	DS-MCE n=25 Participants outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination. DS-MCE: During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
Degree of Comfort	0.96 score on a scale Interval 0.0 to 3.0

Adverse Events

DS-MCE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Changhai Hospital

Department of Gastroenterology

Phone: 86-21-31161004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place