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Randoimized sham-controlled comparative study on prospective and retrospective detecatability of magnetically-guided capsule panendoscopy for gastrointestinal tumors (MagCam study)

Magnetically-guided capsule panendoscopy for gastrointestinal tumors (MagCam study)

91

Group S 44 patients, Group M 47 patients under 60years of age (30, 31.3%), over 60years old (66, 68.8%) male (76, 79.2%), female (20, 20.8%)

Depiction rates for gastric tumors were not significantly different between Groups M and S, but those for non-neoplastic gastric lesions in Group M were significantly higher than in Group S. Gastric observation rate and recording time were not significantly different between Groups M and S. Depiction rates for colorectal tumors and superficial esophageal cancers were not significantly different between Groups M and S.

There were no severe complications.

Using this system, it is possible to perform CE by co-medicals and at-home CE by patients themselves, and it is expected to be applied to gastrointestinal cancer screening tests in the future.

By magnetically guiding CE from outside the body, detailed CE observation of the stomach, which has been difficult to observe, has become possible. Practical use to painless wireless endoscopy is expected. A randomized, controlled, controlled study was conducted using a small magnetic guidance device that can be operated in a single hand to examine the ability of CE to observe the stomach.

Dec. 31, 2024

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs042180150

Ohmiya Naoki

Fujita Health University Hospital

1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi

shokakan@fujita-hu.ac.jp

Kondo Masashi

Fujita Health University

1-98 Dengakugakubo Kutsukake-cho Toyoake Aichi

+81-562-93-9362

mkond@fujita-hu.ac.jp

Complete

April. 01, 2019

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

single assignment

diagnostic purpose

1. The patient that a document agreement by the free will of the person was provided on enough understanding after having received enough explanation on participating of this study
2. Patients younger than 80 years 20 years old or older at the time of the agreement acquisition

1. dysphagia
2. A patient with the past of the allergic reaction to a drug to use in the final examination
3. A woman who I am pregnant or may become pregnant
4. A patient that an examination of MRI is planned within two weeks after a capsule endoscope
5. Patient having a symptom to let you doubt a gastrointestinal stenosis
6. Patient having the progress cancer of the esophagus with stenosis, stomach cancer, colon cancer
7. Patient with a history of the abdominal radiation exposure
8. Having a pacemaker or defibrillator
9. When it is inappropriate

Both

carcinoma of esophagus,gastric tumor,large intestine tumor

carcinoma of esophagus,gastric tumor,
large intestine tumor

1.Depiction ability of the capsule endoscope according to having magnetic induction or not for known gastrointestinal tumor
2.Depiction ability of the capsule endoscope according to the presence of the magnetic induction for the unknown lesion of the part unlike a known gastrointestinal tumor

1.Inspection time for all gastrointestinal capsule endoscopes according to having magnetic induction or not
2.Quantity of pre-treatment, booster of all gastrointestinal capsule endoscopes according to having magnetic induction or not
3.Patient satisfaction of all gastrointestinal capsule endoscopes according to having magnetic induction or not
4.It is an emergency phenomenon after the inspection of all gastrointestinal capsule endoscopes according to having magnetic induction or not, inspection

+81-562-93-2865

July. 11, 2019

None