An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD) (CS005)

An Investigation of the Effect of Long-Term Electrical Stimulation on Lower Esophageal Sphincter (LES) Pressure and Esophageal Acid Exposure in Patients with Gastroesophageal Reflux Disease (GERD) (CS005) - The long term effect of EndoStim

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36042

Enrollment

Registered

2011-07-26

Start date

2011-08-10

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heartburn

Interventions

The EndoStim LES Stimulation System is an investigational device intended to improve the LES pressure and restore LES function in individuals suffering from GERD.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subject has a history of heartburn, regurgitation or both for >6 month. Baseline GERD HRQL heartburn score of >= 20 off PPI assessed during the run in phase. Excessive acid exposure during 24-hour pH-metry of antisecretory therapy

Exclusion criteria

Exclusion criteria: Subject has any non-GERD esophageal motility disorders. Subject has gastroparesis. Subject has a hiatal hernia larger than 3 cm. Subject has significant cardiac arrhythmia or ectopy or significant cardiovascular disease. Subject is pregnant or intends to become pregnant during the trial period. History of previous esophageal or gastric surgery, including nissen fundoplication.

Design outcomes

Primary

Measure	Time frame
Primary Safety Endpoint: Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device implant and completion of the Week 12 evaluation: (1) death, or (2) medical morbidity associated with the device and/or implantation procedure, including cardiac arrhythmias, pneumonia, wound infection, IPG or lead perforation, or significant lead dislocation requiring hospitalization. Safety variables will be tabulated and presented for all patients in the treatment group. Number of patients undergoing device implantation and any reasons for discontinuation of study treatment will be tabulated Primary Functionality Endpoint: functionality will be assessed by the ability of the device to initiate stimulation as programmed and to accurately detect the patient*s posture. Indication of device detection when the patient is lying horizontally and when standing up will be recorded.	—

Measure

Time frame

Primary Safety Endpoint: Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device implant and completion of the Week 12 evaluation: (1) death, or (2) medical morbidity associated with the device and/or implantation procedure, including cardiac arrhythmias, pneumonia, wound infection, IPG or lead perforation, or significant lead dislocation requiring hospitalization. Safety variables will be tabulated and presented for all patients in the treatment group. Number of patients undergoing device implantation and any reasons for discontinuation of study treatment will be tabulated Primary Functionality Endpoint: functionality will be assessed by the ability of the device to initiate stimulation as programmed and to accurately detect the patient*s posture. Indication of device detection when the patient is lying horizontally and when standing up will be recorded.

—

Secondary

Measure	Time frame
a. Change in patient*s GERD-HRQL from baseline (as measured while off PPI) to 3 months. b. The baseline LES end expiratory pressure (LESPpre) and the on-stimulation LES end expiratory pressure (LESPpost) at three months. c. The baseline pH values of % 24-hour esophageal pH1minute and >5 minute duration with the same on-stimulation pH parameters at three months. d. Baseline symptoms as measured by patient symptom diary and patients quality of life measured by SF-12 with on-stimulation symptoms and QOL at three months. e. Decrease in antisecretory medication use compared to baseline.	—

Measure

Time frame

a. Change in patient*s GERD-HRQL from baseline (as measured while off PPI) to 3 months. b. The baseline LES end expiratory pressure (LESPpre) and the on-stimulation LES end expiratory pressure (LESPpost) at three months. c. The baseline pH values of % 24-hour esophageal pH1minute and >5 minute duration with the same on-stimulation pH parameters at three months. d. Baseline symptoms as measured by patient symptom diary and patients quality of life measured by SF-12 with on-stimulation symptoms and QOL at three months. e. Decrease in antisecretory medication use compared to baseline.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)