Gastroesophageal Reflux Disease (GERD) Clinical Trial
Official title:
A Worldwide Post-Market Surveillance Registry to Assess the Medigus Ultrasonic Surgical Endostapler (MUSE™) System for the Treatment of GERD
This registry is intended as an observational, post-marketing surveillance tool. The registry allows collection of baseline demographics and user experience of the commercially available MUSE system. Data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study.
The registry evaluates the MUSE System which creates a transoral anterior fundoplication for
the treatment of GERD. The system enables the operator to staple the fundus of the stomach
to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. The
procedure is performed transorally under general anesthesia. The procedural result is
anatomically and functionally similar to standard anterior fundoplication (Dor-Thal
operation). The staples are standard, 4.8mm titanium surgical staples. Each application of
the device fires a quintuplet of staples (5) in three staggered rows. Anti-retching
medications at the time of the procedure are essential.
The study population will be primarily adults aged 18-70 years selected by the investigators
based on SAGES guidelines for fundoplication and consideration of the indications and
contraindications listed in the device Instructions for Use (IFU).
Follow-up data will be collected at 6 months, 1, 2 and 3 years post procedure.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03561883 -
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
|
Phase 3 | |
| Completed |
NCT02555852 -
Proton Pump Inhibitors and Risk of Community-acquired Pneumonia
|
N/A | |
| Completed |
NCT01406210 -
RESULT (REflux Surgery in Lung Transplantation) Preliminary Study Protocol
|
N/A | |
| Terminated |
NCT01327963 -
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study
|
N/A | |
| Completed |
NCT01570842 -
Anthropometry in Gastroesophageal Reflux Disease and Esophageal Injury
|
N/A | |
| Completed |
NCT02141711 -
TAK-438 - Safety, Blood Levels & Effects of Repeated Doses
|
Phase 1 | |
| Terminated |
NCT00587275 -
Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard Dose of PPI
|
Phase 2 | |
| Completed |
NCT00228527 -
Esomeprazole for Treatment of GERD in Pediatric Patients
|
Phase 4 | |
| Completed |
NCT00261300 -
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
|
Phase 3 | |
| Recruiting |
NCT04506593 -
Indiana University Gastrointestinal Motility Diagnosis Registry
|
||
| Completed |
NCT00795093 -
Partial Response to Proton Pump Inhibitors (PPI) Treatment: The Cost to Society and the Burden to the Patient - a Study in the US
|
N/A | |
| Completed |
NCT00394472 -
Symptom Improvements in Gastroesophageal Reflux Disease (GERD) Patients
|
Phase 2 | |
| Completed |
NCT00574925 -
Study to Assess Management Strategies for the Use of Esomeprazole (Nexium) in Helicobacter Pylori Infected Patients
|
Phase 4 | |
| Terminated |
NCT02749071 -
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
|
N/A | |
| Recruiting |
NCT01129713 -
Comparison of Nexium Versus Secretol in the Healing and Controlling of Symptoms in GERD Patients With Severe EE.
|
Phase 1/Phase 2 | |
| Completed |
NCT00734747 -
Safety and Efficacy the Medigus SRS Endoscopic Stapling System in Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
| Completed |
NCT00312806 -
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
|
Phase 3 | |
| Not yet recruiting |
NCT05579587 -
Transoral Incisionless Fundoplication (TIF) for Laryngopharyngeal Reflux (LPR) Patients
|
||
| Completed |
NCT01374074 -
Racial Disparity in Barrett's Esophagus
|
N/A | |
| Terminated |
NCT00857597 -
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
|
Phase 3 |