Clinical Trials Logo

Clinical Trial 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 treatment.Thirty 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.

Clinical Trial Description

Gastroesophageal reflux disease (GERD) is a neuromuscular disorder with abnormal reflux of gastric contents into the esophagus.The most common symptoms are heartburn, dysphagia, and regurgitation.Due to less invasion, several endoscopic treatments of GERD have been investigated, such as collagen or radio frequency delivery, and antireflux mucosectomy(ARMS).The 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 setting.The aim of this study was to assess the feasibility and safety of the pre-test treatment. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05192538
Study type Interventional
Source Affiliated Hospital to Academy of Military Medical Sciences
Contact Yan Liu
Phone 13911798288
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 10, 2022
Completion date May 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT03568825 - Response Surface Pathway Design With Two Interventional- and One Response Variable in Estimating Minimum Efficacy Dose N/A
Recruiting NCT04703374 - A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects Phase 1
Enrolling by invitation NCT04120025 - Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients N/A
Withdrawn NCT04771247 - Endoscopic Cardiac Band Ligation for the Management of Refractory GERD After Laparoscopic Sleeve Gastrectomy N/A
Completed NCT02575287 - Minimal Injuries From Esophagus Detected by Optical Enhancement Systemâ„¢ Associated to Optical Magnification HD Scopes N/A
Completed NCT01710800 - Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy N/A
Completed NCT00287339 - The Utility of Nexium in Chronic Cough and Reflux Disease Phase 4
Completed NCT00287391 - Sleep Disorders and Gastroesophageal Reflux Disease (GERD) Phase 4
Completed NCT00629564 - An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD) Phase 4
Completed NCT03558477 - PK/PD Clinical Trial of YYD601 in Healthy Adult Male Phase 1
Recruiting NCT05042063 - Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
Enrolling by invitation NCT05069493 - Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Completed NCT03238534 - Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS Phase 4
Recruiting NCT05108038 - A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects Phase 1
Recruiting NCT02587910 - Melanole, a Dietary Supplement, for the Treatment of Gastroesophageal Reflux Disease Phase 2/Phase 3
Suspended NCT02142998 - A Prospective Blinded Randomized Study Comparing Laparoscopic Sleeve Gastrectomy and Laparoscopic Roux-en-y Gastric Bypass and Their Effect on Gastro-Esophageal Reflux Disease Using 24 Horus pH Monitoring N/A
Not yet recruiting NCT02274636 - Study of a Dietary Supplement for Reflux During Sleep N/A
Terminated NCT00536328 - What is the Predictive Value of the Reflux Impact Scale N/A
Completed NCT00388453 - Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease Phase 3