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Capsule EndoscopyNCT03977935

The Second-Generation MCCG for Upper Gastrointestinal Tract.

A study testing the second-generation MCCG in people with Capsule Endoscopy, run by Changhai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Capsule Endoscopy
What is being tested?
the second-generation MCCG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
10 May 2019to 25 Jul 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy
  • Refused abdominal surgery to take out the capsule in case of capsule retention
  • Implanted pacemaker, except the pacemaker is compatible with MRI
  • Other implanted electromedical devices or magnetic metal foreign bodies
  • Pregnancy or suspected pregnancy

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changhai Hospital

    Shanghai, 200433

Other trials in China

About this study

Official title: Second-generation Versus First-generation Magnetically Controlled Capsule Gastroscopy for Upper Gastrointestinal Tract: a Randomized Controlled Clinical Trial.

The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.

Read the detailed description

Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice for gastric examination. However, there still exist blind spots under MCCG, particularly in the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the main cause, MCCG still needs technical improvement. In addition, the gastric examination time under MCCG can be further optimized.

Therefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to 0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective and stable information transmission method.

This is a prospective, single-centered, blinded randomized controlled pilot study. Subjects receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio of 1:1 before the procedure, the first-generation or the second-generation MCCG. After passage through the esophagus, the gastric examination and transpyloric passage of the capsule is conducted under magnetic steering, and then examination is continued in the small bowel under intestinal peristalsis.

Being tested
the second-generation MCCG
Keywords
SG-MCCG, Z-line visualization, Image quality, Gastric examination time, Manipulation performance

What participants receive

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

  • the second-generation MCCGDevice

    Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).

Study groups in NCT03977935
Study groupRoleWhat they receive
The first-generation MCCG groupNo interventionThe patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the "360-degree automatic scanning" mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the "small-bowel mode". The magnetic steering time for passing through the pylorus was not allowed more than 15 min.
The second-generation MCCG groupExperimentalAll process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
Receives: Device: the second-generation MCCG

What is being measured

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

  1. Circumferential Visualization of the Z-line

    Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (>75%) observed; and entire Z line (100%) observed.

    Measured: Through end of examination, up to 30 minutes

Secondary outcomes (10)

  1. Detection Rate of Duodenal Papilla

    Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained

    Measured: up to 2 days after the examination

  2. Gastric Examination Time (GET)

    Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).

    Measured: Through end of examination, up to 30 minutes

  3. Manipulation Performance Score of the MCCG

    The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best.

    Measured: up to 10 minutes after the examination

  4. Image Quality Score (Mainly Focus on Clarity)

    Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).

    Measured: up to 30 minutes after the examination

  5. The Number of Images Captured for Esophagus and Z-line

    The number of images captured by MCCG for esophagus and Z-line.

    Measured: up to 30 minutes after the examination

  6. Number of Participants With Lesions in Upper Gastrointestinal Tract

    calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.

    Measured: up to 2 days after the examination

  7. Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time

    Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.

    Measured: up to 2 days after the examination

  8. Cleansing Level Score of Z-line Area

    The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.

    Measured: Through end of examination, up to 30 minutes

  9. The Incidence of Adverse Events (The Safety of MCCG)

    The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.

    Measured: up to 2 weeks after the examination

  10. Transit Time of MCCG in Esophagus

    Assess the transit time of MCCG in esophagus from starts take images to ends.

    Measured: up to 2 days after the examination

Timeline

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

  1. First posted6 Jun 2019
  2. Study start10 May 2019
  3. Primary completion18 Jul 2019
  4. Study completion25 Jul 2019

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03977935
Sponsor's protocol ID
SG-MCCG-UGT
Status last verified
Jun 2019
First submitted
3 Jun 2019
Last updated
27 Oct 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jiang B, Qian YY, Pan J, Jiang X, Wang YC, Zhu JH, Zou WB, Zhou W, Li ZS, Liao Z. Second-generation magnetically controlled capsule gastroscopy with improved image resolution and frame rate: a randomized controlled clinical trial (with video). Gastrointest Endosc. 2020 Jun;91(6):1379-1387. doi: 10.1016/j.gie.2020.01.027. Epub 2020 Jan 22.

    PubMed 31981648

Questions about this trial

What is this clinical trial studying?

A study testing the second-generation MCCG in people with Capsule Endoscopy, run by Changhai Hospital at 1 site 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 27 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circumferential Visualization of the Z-line (time frame: Through end of examination, up to 30 minutes). 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 NCT03977935, which also lists 1 linked publication.

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 27 Oct 2020.

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