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

NCT ID: NCT05459714

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-05-01

Brief Summary

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).

Detailed 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).

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MCE for obese patients

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.

Group Type: EXPERIMENTAL

MCE for obese patients

Intervention Type: DEVICE

Sequence of stomach examination: The stomach examination is performed sequentially according to the order of fundus, cardia, gastric body, angulus, antrum, and pylorus, which should ensure the integrity of the observation of each part of the stomach and achieve the purpose of comprehensive observation by means of different observation distances such as distant view and close view, and different observation angles such as front and side.

Interventions

MCE for obese patients

Sequence of stomach examination: The stomach examination is performed sequentially according to the order of fundus, cardia, gastric body, angulus, antrum, and pylorus, which should ensure the integrity of the observation of each part of the stomach and achieve the purpose of comprehensive observation by means of different observation distances such as distant view and close view, and different observation angles such as front and side.

Intervention Type: DEVICE

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Liao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pin Zhang

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Kai Yin

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Bin Wang

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Locations

Changhai Hospital

Shanghai, , China

Shanghai Ninth People's Hospital

Shanghai, , China

Shanghai Sixth People's Hospital

Shanghai, , China

Countries

China

Central Contacts

Zhuan Liao

Role: CONTACT

liaozhuan@smmu.edu.cn

86-21-31161004

Facility Contacts

Kai Yin

Role: primary

Bing Wang

Role: primary

Pin Zhang

Role: primary

References

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Other Identifiers

MCE for obese patients

Identifier Type: -

Identifier Source: org_study_id