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Esophageal DiseasesNCT05469152

Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases

A study testing ds-MCE and EGD in people with Esophageal Diseases, run by Changhai Hospital at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of the study is to determine the accuracy of detachable string magnetically controlled capsule endoscopy(DS-MCE) as a follow-up method for patients with previous esophageal diseases. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Diseases
What is being tested?
ds-MCE and EGD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
7 sitesChina
Study dates
15 Jul 2019to 15 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Gender is not limited.
  • Patients aged between 18-75 years or older.
  • Both inpatients and outpatients.
  • Patients with previous esophageal diseases who are scheduled to undergo EGD for follow-up.
  • Able to provide informed consent.

Who cannot join

  • Patients aged less than 18 years.
  • Patients with active upper gastrointestinal bleeding.
  • Patients who have participated in or are participating in other clinical trials within three months.
  • Patients with cancer on active treatment with chemotherapy and/or radiation therapy.
  • Pregnancy or suspected pregnancy.
  • Suspected or known intestinal stenosis or other known risk factors for capsule retention.
  • Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance.
  • Patients with dysphagia.

Trial locations and contacts

7 sites in 1 country.

Zhuan Liao contact

86-21-31161004

liaozhuan@smmu.edu.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • Ruijin Hospital

    Shanghai

    Duowu Zou, zdw_pi@163.com

    Recruiting

  • Shanghai Changhai Hospital

    Shanghai

    Zhuan Liao

    Recruiting

  • Shanghai General Hospital

    Shanghai

    Xinjian Wan, slwanxj2019@163.com

    Recruiting

  • Shanghai Sixth People's Hospital

    Shanghai

    Jinshui Zhu

    Recruiting

  • Xuhui District Central Hospital

    Shanghai

    Yunshi Zhong

    Recruiting

  • Yangpu District Central Hospital

    Shanghai

    Li Li, 11i10437@sina.com

    Recruiting

  • Zhongshan Hospital

    Shanghai

    Pinghong Zhou

    Recruiting

Other trials in China

About this study

Official title: Accuracy of Detachable String Magnetically Controlled Capsule Endoscopy for Follow-up of Patients With Esophageal Diseases: A Multicenter Study

The purpose of the study is to determine the accuracy of detachable string magnetically controlled capsule endoscopy(DS-MCE) as a follow-up method for patients with previous esophageal diseases.

Read the detailed description

Esophagogastroduodenoscopy (EGD) is recognized as the gold standard for detection and follow-up of esophageal diseases,allowing for direct mucosal visualization and therapeutic intervention. EGD is however an invasive procedure and there is potential for procedure-related complications, such as perforation and bleeding.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.

The ds-MCE system consists of two parts: the magnetically controlled capsule endoscopy (MCE) system and a transparent latex sleeve with a hollow string. The magnetically controlled capsule endoscopy (MCE) system (Ankon Technologies, Shanghai, China) detects focal lesions in the stomach with comparable accuracy with conventional EGD. One end of the hollow string is a transparent thin latex sleeve that can be wrapped on the surface of the capsule, and the other end of the string is connected to the syringe. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. In this case, investigator can examine the entire esophageal mucosa several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. The pilot study of ds-MCE confirmed it was a feasible, safe and well-tolerated method for completely viewing esophagus and stomach, without the need for sedation. Besides, the 8-10h battery life of the ds-MCE enables complete examination of the small bowel, which provides the possibility for screening pathological changes in the entire gastrointestinal tract.

This study is a prospective, multi-centered, diagnostic accuracy study. The primary outcome is the diagnostic accuracy of ds-MCE in identifying esophageal diseases. Second outcomes include the visualization and cleanliness of Z-line, safety and patient satisfaction of DS-MCE.

Being tested
ds-MCE and EGD
Keywords
esophageal diseases, capsule endoscopy
Medical subject headings
Esophageal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ds-MCE and EGDDiagnostic test

    Procedure of ds-MCE: The ds-MCE system mainly consists of two parts: the NaviCam magnetic capsule endoscopy guidance system and the detachable string part. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. Investigator can examine the entire esophagus several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. Then, the examination of stomach under magnetic control and small bowel under the natural action of peristalsis follows.

    Procedure of EGD: The EGD will be performed using conventional upper gastrointestinal video endoscopy, according to the standard procedure at individual centers. EGD will be performed within 48 hours after ds-MCE procedure and usually during the same endoscopic session.

Study groups in NCT05469152
Study groupRoleWhat they receive
ds-MCE and EGDExperimentalAll the enrolled participants will undergo the examination of detachable string magnetically controlled capsule endoscopy (ds-MCE) first, followed by EGD within 48 hours.
Receives: Diagnostic Test: ds-MCE and EGD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The diagnostic accuracy of the ds-MCE in identifying esophageal diseases in comparison to standardized EGD

    To assess the diagnostic accuracy of the ds-MCE as a follow-up method for patients with previous esophageal diseases, using EGD as the gold standard.

    Measured: 2 weeks

Secondary outcomes (4)

  1. Number of quadrants visualized at Z-line by ds-MCE

    To assess the visualization of Z-line. Circumferential visualization of the Z line by ds-MCE was defined by quadrants as follows: Z line not observed at all; less than 2 quadrants (< 50 %) of the Z line observed; between 2 quadrants and 3 quadrants (50 % - 75%) observed; more than 3 quadrants (> 75%) observed; and entire Z line (100 %) observed.

    Measured: 2 weeks

  2. Scores of cleanliness of Z-line area

    The effect of bubbles/saliva on the appearance of the Z line area was scored as follows: 0 = no interference by bubbles/saliva on the Z line area; 1 = minor interference of bubbles/saliva on the Z line area; 2 = major interference of bubbles/saliva on the Z line area.

    Measured: 2 weeks

  3. Number of ds-MCE associated adverse events

    To assess the safety of ds-MCE.

    Measured: 2 weeks

  4. The patient satisfaction of the ds-MCE through questionnaires

    To assess the patient satisfaction of the ds-MCE compared to standard EGD.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2022
  2. Study start15 Jul 2019
  3. Primary completion15 Sep 2022 (estimated)
  4. Study completion15 Sep 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469152
Sponsor's protocol ID
DS-MCE-esophagus
Status last verified
Jul 2022
First submitted
11 Jul 2022
Last updated
21 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After finishing this study, we will make the data available to other researchers: including study protocol, statistical analysis plan (SAP), informed consent form (ICF), clinical study report (CSR)

Publications

  • 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.

    PubMed 30822803

  • de Franchis R, Eisen GM, Laine L, Fernandez-Urien I, Herrerias JM, Brown RD, Fisher L, Vargas HE, Vargo J, Thompson J, Eliakim R. Esophageal capsule endoscopy for screening and surveillance of esophageal varices in patients with portal hypertension. Hepatology. 2008 May;47(5):1595-603. doi: 10.1002/hep.22227.

    PubMed 18435461

  • Chen WS, Zhu LH, Li DZ, Chen L, Wu YL, Wang W. String esophageal capsule endoscopy with real-time viewing improves visualization of the distal esophageal Z-line: a prospective, comparative study. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):309-12. doi: 10.1097/MEG.0000000000000038.

    PubMed 24429971

  • de Franchis R. Updating consensus in portal hypertension: report of the Baveno III Consensus Workshop on definitions, methodology and therapeutic strategies in portal hypertension. J Hepatol. 2000 Nov;33(5):846-52. doi: 10.1016/s0168-8278(00)80320-7. No abstract available.

    PubMed 11097497

  • Zou WB, Hou XH, Xin L, Liu J, Bo LM, Yu GY, Liao Z, Li ZS. Magnetic-controlled capsule endoscopy vs. gastroscopy for gastric diseases: a two-center self-controlled comparative trial. Endoscopy. 2015 Jun;47(6):525-8. doi: 10.1055/s-0034-1391123. Epub 2015 Jan 15.

    PubMed 25590177

  • Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.

    PubMed 27211503

  • Liao Z, Gao R, Xu C, Xu DF, Li ZS. Sleeve string capsule endoscopy for real-time viewing of the esophagus: a pilot study (with video). Gastrointest Endosc. 2009 Aug;70(2):201-9. doi: 10.1016/j.gie.2008.10.043. Epub 2009 Mar 14.

    PubMed 19286182

  • Hosoe N, Naganuma M, Ogata H. Current status of capsule endoscopy through a whole digestive tract. Dig Endosc. 2015 Jan;27(2):205-15. doi: 10.1111/den.12380. Epub 2014 Oct 20.

    PubMed 25208463

Questions about this trial

What is this clinical trial studying?

A study testing ds-MCE and EGD in people with Esophageal Diseases, run by Changhai Hospital at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhuan Liao (86-21-31161004, liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The diagnostic accuracy of the ds-MCE in identifying esophageal diseases in comparison to standardized EGD (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05469152, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.

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