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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03457909
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Outpatients	Device: DS-MCE	N/A

Detailed Description

Esophageal capsule endoscopy(ECE)provides a novel noninvasive approach to visualize the esophagus.The main drawback for the use of ECE is its unreliable transit time which often renders an inadequate visualization of the esophagus.Thus investigators have developed the detachable string magnetically controlled capsule endoscopy(DS-MCE) which can control the movement of the capsule through the string.

This study is a prospective, single-centered, self-controlled pilot study.Outpatients who have esophagus symptoms will take conventional endoscopy examination and DS-MCE successively.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Novel Detachable String Magnetically Controlled Capsule Endoscopy (DS-MCE) for Viewing Esophagus and Stomach
• Actual Study Start Date: Mar 7, 2018
• Actual Primary Completion Date: Jul 10, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DS-MCE outpatients who have esophagus symptoms will take DS-MCE and conventional endoscopy examination examination successively.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach [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.

Secondary Outcome Measures

1. Number of DS-MCE Associated Adverse Events [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.

2. Duration of Time Capsule is Within the Esophagus [up to 2 weeks]

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

3. Z-line Visualization [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.

4. Quality Score of Z-line Images [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)

5. Degree of Comfort [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• outpatients who have esophagus symptoms.

Exclusion Criteria:

• known or suspected complex history of gastrointestinal obstruction, stenosis or fistula.

• dysphagia or delayed gastric emptying.

• known or suspected possibility of active bleeding of digestive tract.

• a history of abdominal operation.

• pacemaker implantation and gastrointestinal pacemaker users.

• patients who are allergic to simethicone or pronase.

• pregnant women,mental patients.

• other circumstances that doctors consider inappropriate for the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital	Shanghai	Shanghai	China	200433

Sponsors and Collaborators

• Changhai Hospital

Investigators

• Study Chair: Zhuan Liao, Changhai Hospital

Study Documents (Full-Text)

• Study Protocol - Mar 1, 2018
• Statistical Analysis Plan - Mar 1, 2018

More Information

Publications

None provided.

• Responsible Party: Zhuan Liao, associate professor, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT03457909
• Other Study ID Numbers: DS-MCE-esophagus and stomach
• First Posted: Mar 8, 2018
• Last Update Posted: Sep 23, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhuan Liao, associate professor, Changhai Hospital: string; capsule endoscopy

Study Results

Participant Flow

Recruitment Details	Healthy volunteers or patients with suspected esophageal diseases were prospectively enrolled in Changhai Hospital from March 2018 to June 2018.
Pre-assignment Detail	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.

Arm/Group Title	DS-MCE
Arm/Group Description	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.
Period Title: Overall Study
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	DS-MCE
Arm/Group Description	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.
Overall Participants	25
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54
Sex: Female, Male (Count of Participants)
Female	7 28%
Male	18 72%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
China	25 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach
Description	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.
Time Frame	up to 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DS-MCE
Arm/Group Description	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.
Measure Participants	25
Count of Participants [Participants]	25 100%

2. Secondary Outcome

Title	Number of DS-MCE Associated Adverse Events
Description	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.
Time Frame	up to 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DS-MCE
Arm/Group Description	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.
Measure Participants	25
Number [adverse events]	0

3. Secondary Outcome

Title	Duration of Time Capsule is Within the Esophagus
Description	time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach
Time Frame	up to 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DS-MCE
Arm/Group Description	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.
Measure Participants	25
Median (Full Range) [minutes]	6.2

4. Secondary Outcome

Title	Z-line Visualization
Description	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.
Time Frame	up to 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DS-MCE
Arm/Group Description	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.
Measure Participants	25
Number [participants]	20 80%

5. Secondary Outcome

Title	Quality Score of Z-line Images
Description	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)
Time Frame	up to 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DS-MCE
Arm/Group Description	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.
Measure Participants	25
Mean (Full Range) [score on a scale]	0.68

6. Secondary Outcome

Title	Degree of Comfort
Description	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).
Time Frame	up to 2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DS-MCE
Arm/Group Description	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.
Measure Participants	25
Mean (Full Range) [score on a scale]	0.96

Adverse Events

Time Frame	All patients were followed up to 2 weeks to confirm capsule excretion and any adverse events.
Adverse Event Reporting Description	strings and sleeves ruptured, capsule lost, asipration of the capsule，severe choking cough and death.
Arm/Group Title	DS-MCE
Arm/Group Description	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.
All Cause Mortality
	DS-MCE
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	DS-MCE
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	DS-MCE
	Affected / at Risk (%)	# Events
Total	0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.