Clinical trial NCT05459714: Magnetically Controlled Capsule Endoscope System in Stomach Examination of Moderately and Severely Obese Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obesity
capsule endoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai 6th People's Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2022-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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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Primary outcomes:
measure: Number of Participants With Complete Observation
timeFrame: 2 weeks
Secondary outcomes:
measure: Gastric Examination Time
timeFrame: 2 weeks
measure: The Total Number of Patients Who Who Had a Diagnosis of Positive Findings
timeFrame: 2 weeks
measure: Evaluation of patient satisfaction through questionaires
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Pin Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital
name: Kai Yin
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Bin Wang
role: PRINCIPAL_INVESTIGATOR
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