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Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying

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ClinicalTrials.gov Identifier: NCT03441945
Recruitment Status : Unknown
Verified February 2018 by Zhuan Liao, Changhai Hospital.
Recruitment status was:  Recruiting
First Posted : February 22, 2018
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Brief Summary:
The research continuously enrolled 100 patients undergone MCCG between May to December 2017 as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and randomly selected 100 patients before May 2017 from the database as the control group with passive movement of the capsule. The difference of the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the two groups were compared, and related factors were also investigated.

Condition or disease Intervention/treatment Phase
Capsule Endoscopy Gastric Emptying Other: magnetic steering Not Applicable

Detailed Description:

Background and Aims: Capsule endoscopy is a valuable tool in the diagnosis of small bowel disease. However, the incompletion of small bowel examination may reduce the diagnostic accuracy, which mainly caused by delayed capsule gastric emptying. Thus the aim of this study was to validate the effect of magnetic steering on enhancing gastric emptying and mucosal visualization within duodenum during magnetically controlled capsule gastroscopy (MCCG) examination.

Methods: As a historical prospective cohort study, the research continuously enrolled 100 patients undergone MCCG between May to December 2017 as the intervention group with magnetic steering of capsule in the pylorus and duodenum, and randomly selected 100 patients before May 2017 from the database as the control group with passive movement of the capsule. The difference of the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the two groups were compared, and related factors were also investigated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: New Method: Can Magnetic Steering Enhance Capsule Gastroscopy Gastric Emptying?
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : February 28, 2018

Arm Intervention/treatment
No Intervention: control
The patients swallowed the capsule with water in the lying position.After finishing the stomach examination, the operation of the capsule is adjusted to "small bowel mode" without magnetic control. Capsule entered the duodenum under physiological peristalsis. The position of the capsule was established using a real-time viewer. If the capsule failed to enter the duodenum after one hour, domperidone (10 mg) was orally administered.
Experimental: magnetic steering
After finishing the stomach examination as the control protocol, the capsule was lifted with the magnetic control, then rotating the capsule until the camera end oriented toward the pylorus . Next, the endoscopist could drag the capsule close to the pylorus with the guidance magnet robot, waiting for the open of pylorus. Once the pylorus opened, the capsule could enter the duodenum with gastric peristalsis. After reaching the duodenal bulb, capsule was held to the maximum position of "Z", then the capsule would scan the duodenal bulb automatically with the mode "360° automatic scanning".
Other: magnetic steering
magnetic steering




Primary Outcome Measures :
  1. PTT [ Time Frame: 3 month ]
    pyloric transit time


Secondary Outcome Measures :
  1. DPDR [ Time Frame: 3 month ]
    duodenal papilla detection rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. patients over 18 years of age undergone MCCG examination in Changhai Hospital

Exclusion Criteria:

  1. pregnancy or suspected pregnancy;
  2. suspected or known intestinal stenosis;
  3. pacemaker, other implanted electro medical devices which could interfere with magnetic resonance; (4) undergone a known surgery which could possibly affect visualization of the duodenal papilla;

(5) other conditions which may lead to capsule retention.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03441945


Locations
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China
Shanghai Changhai Hospital Recruiting
Shanghai, China
Contact: Zhao-shen Li    13127952352    zhaoshen-li@hotmail.com   
Contact: Zhuan Liao       liaozhuan@smmu.edu.cn   
Sub-Investigator: Xi Jiang         
Sponsors and Collaborators
Zhuan Liao
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhuan Liao, professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03441945    
Other Study ID Numbers: MS-enhance-MCCG-GE
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We may share IPD when we finish this study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Liao, Changhai Hospital:
Magnetic
Capsule Endoscopy
enhance
gastric emptying