Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05192538
Status:
UNKNOWN
Last Update Posted:
2022-03-16
First Post:
2021-11-29
Brief Title:
A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux
Sponsor:
Affiliated Hospital to Academy of Military Medical Sciences
Organization:
Affiliated Hospital to Academy of Military Medical Sciences
Study Overview
Official Title:
A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux Before Anti-reflux Surgery or Endoscopic Treatment
Status:
UNKNOWN
Status Verified Date:
2022-03
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:
The purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment In the study the investigators used the novel pre-test to narrow the gastric cardia to control symptoms temporarily to decide whether to undergo irreversible surgery or endoscopic treatmentThirty patients were enrolled and underwent endoscopic endoloop pre-test treatment The Primary outcome in this study was measured by the percent reduction in post-procedure GERD symptoms as evidenced by analysis of the GERD-HRQL Health Related Quality of Life questionnaire The secondary outcomes included improvement in esophageal 24-hr pH monitoring improvement in quality of life questionnaires and safety Patient follow-up assessments were completed at 7 and 14 days post treatment
Detailed Description:
Gastroesophageal reflux disease GERD is a neuromuscular disorder with abnormal reflux of gastric contents into the esophagusThe most common symptoms are heartburn dysphagia and regurgitationDue to less invasion several endoscopic treatments of GERD have been investigated such as collagen or radio frequency delivery and antireflux mucosectomyARMSThe disadvantages of these treatment included short-term effectiveness increasing reflux and ulcer and serious complications A novel endoscopic endoloop pre-test treatment has been developed offering a minimally reversible endoscopic treatment to predict whether the symptoms can be alleviated in order to ultimately decide whether to undergo irreversible surgery or endoscopic treatment which can be performed in an outpatient settingThe aim of this study was to assess the feasibility and safety of the pre-test treatment
Study Oversight
Has Oversight DMC:
None
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?:
None