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

Study Overview
=================
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).

Official Title
-----------------
A Prospective Study to Evaluate the Feasibility and Safety of Magnetically Controlled Capsule Endoscope System in Stomach Examination of Moderately and Severely Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: MCE for obese patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of obesity: BMI ≥ 35kg/m2; Be scheduled to undergo gastric examination; 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. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MCE for obese patients<br>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. | Device: MCE for obese patients<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Observation | The number of participants with complete observation. Complete observation of the mucosa means over 90% of the mucosa observed in gastric cardia, fundus, body, angulus, antrum and pylorus. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric Examination Time | Gastric examination time was defined as the time taken for the endoscopist to complete the gastric examination to his or her satisfaction | 2 weeks | 
| The Total Number of Patients Who Who Had a Diagnosis of Positive Findings | It was calculated using the following formula: number of patients with positive findings divided by the total number of patients that underwent examination. | 2 weeks | 
| Evaluation of patient satisfaction through questionaires | The investigators use a satisfaction questionnaire to evaluate the satisfaction of each patient, including ease of capsule swallowing, discomfort during the examination, discomfort after the examination and comfort level of MCE examination. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, capsule endoscopy