Viewing Study NCT05249933


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Study NCT ID: NCT05249933
Status: UNKNOWN
Last Update Posted: 2022-02-22
First Post: 2022-02-09
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Pronase Granules in Gastric Cleaning
Sponsor: Changhai Hospital
Organization:

Study Overview

Official Title: The Efficiency of Pronase Granules in Gastric Cleaning of Magnetically Controlled Capsule Endoscopy: a Prospective Randomized Controlled Study
Status: UNKNOWN
Status Verified Date: 2021-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Magnetically controlled capsule endoscopy (MCE) is now widely used all over the world. However, the standard gastric preparation method by dimethicone we used clinically still has mucus at the bottom of the stomach. In this study, we aimed to determine whether pronase granules is helpful to improve the cleanliness of gastric mucosa in MCE.
Detailed Description: As a non-invasive and well-tolerated gastrointestinal examination method, magnetically controlled capsule endoscopy (MCE) is being increasingly used in different populations in recent years. Gastric preparation is extremely important for the completion rate (CR), image quality, and diagnostic efficiency because of the plica of gastric mucosa and the autonomous movement of the capsule in the gastrointestinal tract. After a series of explorations including air-producing powder, defoamer, protease preparation, patients are asked to drink about 800 ml-1000 ml water in a short time for standard gastric filling. However, the existing problems of gastric preparation such as abdominal distension, insufficient gastric filling, and long gastric retention time deserve attention. Different from the results of Zhu et al. (DLD, 2017), the current clinical experience shows that the addition of pronase granules in gastric preparation can often reduce the mucus in the stomach. But the standardized use of pronase granules remains to be further explored.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: