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

July 14, 2022 updated by: Zhuan Liao, Changhai Hospital

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Ninth People's Hospital
        • Contact:
          • Bing Wang
      • Shanghai, China
        • Changhai Hospital
      • Shanghai, China
        • Shanghai Sixth People's Hospital
        • Contact:
          • Pin Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Complete Observation
Time Frame: 2 weeks
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
Time Frame: 2 weeks
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
Time Frame: 2 weeks
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
Time Frame: 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai 6th People's Hospital

Investigators

  • Principal Investigator: Pin Zhang, Shanghai 6th People's Hospital
  • Principal Investigator: Kai Yin, Changhai Hospital
  • Principal Investigator: Bin Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (Actual)

July 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCE for obese patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After finishing this study, the investigators will make the data available to other researchers:

including study protocol, statistical analysis plan (SAP), informed consent form (ICF), clinical study report (CSR)

IPD Sharing Time Frame

3 years

IPD Sharing Access Criteria

The website of the journal where the results published, and ClinicalTrials.gov web site.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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