NCT04329468

Brief Summary

This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
Last Updated

July 21, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 27, 2020

Last Update Submit

July 20, 2020

Conditions

Capsule Endoscopy

Keywords

DS-MCEZ-lineDuodenal papillaCompletion rate

Outcome Measures

Primary Outcomes (1)

  • Success rate of UGI and small-bowel examination

    The feasibility of DS-MCE examination with a novel way is evaluated by the technical success rate, a composite outcome including the successful separation of the string and MCE, repeat viewing of esophagus, stomach and duodenum, and complete small-bowel examination.

    up to 2 weeks

Secondary Outcomes (11)

  • Diagnostic accuracy

    up to 2 weeks

  • Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded

    up to 2 weeks

  • Detection rate of Z-line, duodenal papilla and pyloric retrograde view

    up to 2 weeks

  • Circumferential visualization of the Z-line and duodenal papilla

    up to 2 weeks

  • Cleansing level of Z-line and duodenal papilla area

    up to 2 weeks

  • +6 more secondary outcomes

Study Arms (1)

DS-MCE examination

EXPERIMENTAL

Subjects with or without digestive symptoms will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.

Device: DS-MCE

Interventions

DS-MCEDEVICE

The subjects swallowed the MCE to investigate the esophagus repeatedly by pulling up or down the string. After completion of the esophageal examination, MCE reached the stomach and was lifted away from the posterior wall, rotated if necessary and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination, the capsule would enter the duodenum due to peristalsis when the pylorus opened. Then DS-MCE tried to inspect the duodenum repeatedly under the string and magnetic field control, including view of major papilla in the descending part of duodenum and retrograde view of pylorus in duodenal bulb with a "360-degree automatic scanning" mode. After completion of the duodenum examination, the capsule started to view the small bowel.

DS-MCE examination

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18 to 80
  • With or without gastrointestinal complaints
  • Scheduled to undergo a capsule endoscopy for both stomach and small bowel
  • Signed the informed consents before joining this study

You may not qualify if:

  • Pacemakers or electromedical devices implanted which are incompatible with magnetic field;
  • Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention;
  • Scheduled magnetic resonance imaging examination before excretion of capsule;
  • Pregnancy or suspected pregnancy;
  • Any contraindications about EGD.
  • Other circumstances that doctors consider inappropriate for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

Related Publications (2)

  • Chen YZ, Pan J, Luo YY, Jiang X, Zou WB, Qian YY, Zhou W, Liu X, Li ZS, Liao Z. Detachable string magnetically controlled capsule endoscopy for complete viewing of the esophagus and stomach. Endoscopy. 2019 Apr;51(4):360-364. doi: 10.1055/a-0856-6845. Epub 2019 Mar 1.

    PMID: 30822803BACKGROUND

  • Jiang B, Qian YY, Wang YC, Pan J, Jiang X, Zhu JH, Qiu XO, Zhou W, Li ZS, Liao Z. A novel capsule endoscopy for upper and mid-GI tract: the UMGI capsule. BMC Gastroenterol. 2023 Mar 16;23(1):76. doi: 10.1186/s12876-023-02696-5.

    PMID: 36927462DERIVED

Study Officials

  • Zhuan Liao

    Changhai Hospital, Shanghai, China

    STUDY DIRECTOR

Central Study Contacts

Bin Jiang

CONTACT

15021569528jarz1995@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 27, 2020

First Posted

April 1, 2020

Study Start

March 10, 2020

Primary Completion

August 20, 2020

Study Completion

September 20, 2020

Last Updated

July 21, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)