Magnetically Controlled Capsule Endoscope System in Stomach Examination of Moderately and Severely Obese Patients
NCT05459714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-07-15
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).
Conditions
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Shanghai 6th People's Hospital
collaborator OTHER -
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
collaborator OTHER -
Changhai Hospital
lead OTHER
Principal Investigators
-
Pin Zhang · Shanghai 6th People's Hospital
-
Kai Yin · Changhai Hospital
-
Bin Wang · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-15
- Primary Completion
- 2023-05-01
- Completion
- 2023-05-01
Countries
- China
Study Locations
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