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Completed

NCT Number: NCT03977935

The Second-Generation MCCG for Upper Gastrointestinal Tract.

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.

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Key information

Conditions

Capsule Endoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

the second-generation MCCG

Device

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

Primary outcomes

  1. Circumferential Visualization of the Z-line

    Time frame: Through end of examination, up to 30 minutes

    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.

Secondary outcomes

  1. Detection Rate of Duodenal Papilla

    Time frame: up to 2 days after the examination

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

  2. Gastric Examination Time (GET)

    Time frame: Through end of examination, up to 30 minutes

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

  3. Manipulation Performance Score of the MCCG

    Time frame: up to 10 minutes after the examination

    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.

  4. Image Quality Score (Mainly Focus on Clarity)

    Time frame: up to 30 minutes after the examination

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

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

    Time frame: up to 30 minutes after the examination

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

  6. Number of Participants With Lesions in Upper Gastrointestinal Tract

    Time frame: up to 2 days after the examination

    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.

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

    Time frame: up to 2 days after the examination

    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.

  8. Cleansing Level Score of Z-line Area

    Time frame: Through end of examination, up to 30 minutes

    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.

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

    Time frame: up to 2 weeks after the examination

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

  10. Transit Time of MCCG in Esophagus

    Time frame: up to 2 days after the examination

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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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