Magnetically Controlled Capsule Endoscope System in Stomach Examination of Moderately and Severely Obese Patients

Naval Military Medical University

Status: Not yet enrolling

Conditions: Obesity

Treatments: Device: MCE for obese patients

Study type: Interventional

Funder types: Other

Identifiers

NCT05459714

MCE for obese patients

Details and patient eligibility

About

This study is a prospective, multicenter clinical trial. The study is planned to be conducted at a qualified clinical trial center, and 30 subjects are planned to be enrolled to evaluate the feasibility and safety of magnetically controlled capsule endoscopy (MCE) system in the examination of gastric disorders in patients with moderate to severe obesity (BMI ≥ 35 kg/m2).

Full description

Metabolic surgery, as one of the most important treatments for obesity, has been widely used worldwide. Esophagogastroduodenoscopy (EGD) is mostly used in the perioperative preoperative application of metabolic surgery to improve or exclude preoperative diagnosis, including gastrointestinal tumors, various types of upper GI mucosal lesions, esophagitis, esophageal hiatal hernia, gastrointestinal interstitial tumors, etc. However, EGD is an invasive examination and can cause discomfort without anesthesia, resulting in low patient compliance. In 2013, ANKON took the lead in developing the world's first capsule endoscope system that utilizes precise multi-dimensional rotational movement of a robotic arm and adaptive matching to achieve precise magnetic control, which is convenient for observing specific lesions from an appropriate angle and has been shown to have high diagnostic accuracy for gastric diseases (highly consistent with EGD, with sensitivity and specificity of 90.4% and 95.7%, respectively, and accuracy of 93.4%). It has been clinically proven that MCE is safe and effective in the upper gastrointestinal tract, but there is a lack of clinical systematic studies on its application to moderately and severely obese people.In summary, this exploratory study is designed to preliminarily verify the clinical feasibility and safety of MCE for upper gastrointestinal examination in moderately obese people (BMI ≥ 35 kg/m2).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of obesity: BMI ≥ 35kg/m2;
2. Be scheduled to undergo gastric examination;
3. Be able to provide informed consent.

Exclusion criteria

1. With swallowing obstruction or disorders; 2. With known or suspected gastrointestinal obstruction, stenosis and fistula; 3. Have no conditions for surgery or refuse to undergo any abdominal surgery; 4. Be allergic to or have other known contraindication or intolerance to the drug used in the study; 5. With pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies; 6. Women during pregnancy; 7. Currently enrolled in another clinical trial of a drug or device; 8. Other conditions determined by the investigator to be inappropriate for enrollment.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

MCE for obese patients

Experimental group

Description:

After a standardized gastrointestinal preparation, the patient will undergo MCE examination. After completing the MCE procedure, the patient is evaluated for examination comfort and can then leave the hospital on his or her own and watch for capsule excretion.

Treatment:

Device: MCE for obese patients