Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2018-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to evaluate the safety and efficacy of radiofrequency energy procedure for Gastro-esophageal reflux disease (GERD) based on changes of symptoms, medication esophagitis grade, esophageal acid exposure and lower esophageal sphincter pressure. Symptom assessment was performed at baseline and 3, 6, 12 months after treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

the Efficency and Safety of Stretta in GERD

NCT03574831

GERD Radiofrequency Ablation

UNKNOWN

Outcomes for Patients With Gastro-Esophageal Reflux Disease

NCT03824548

Gastro-esophageal Reflux Disease

UNKNOWN

Evaluation of the Efficiency of Radiofrequency in the Treatment of Gastroesophageal Reflux Disease

NCT00200642

Gastroesophageal Reflux Disease

COMPLETED NA

STRETTA ,Radio Frequency Ablation (RFA) v/s Sham Therapy for the Treatment of Refractory GERD

NCT02935881

GERD

UNKNOWN PHASE3

A Novel Endoloop Pre-test to Treat Gastroesophageal Reflux

NCT05192538

GERD Reflux Esophagitis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Gastroesophageal reflux disease (GERD) is a chronic disease characterized by symptoms of heartburn and acid regurgitation. Uncontrolled GERD can significantly impact quality of life. The use of proton pump inhibitors (PPI) remains the mainstay therapy. However, the efficacy of this intervention is often hampered by adherence, costs, and the risks of long-term PPI use. Anti-reflux surgery is an option for patients with refractory symptoms or in those in whom medical therapy is contraindicated or not desirable, but the incidence of dysphagia, abdominal distension associated wth the surgery is high. Radiofrequency ablation, minimally invasive, less complications, has become alternative treatments options. But the current research on radiofrequency treatment of the data is limited in China. Therefore, the investigators conduct this multi-center clinical trial.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastroesophageal Reflux Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Radiofrequency

Radiofrequency delivery to the gastroesophageal junction

Group Type EXPERIMENTAL

Radiofrequency delivery

Intervention Type PROCEDURE

Radiofrequency to the gastroesophageal junction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiofrequency delivery

Radiofrequency to the gastroesophageal junction

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age 18 years or older
* diagnosis of GERD established by either

* 24-h oesophageal pH monitoring (performed off medications) showing an abnormal OAE (pH \< 4 at least 4% of time) and/or
* an upper gastrointestinal (GI) endoscopy showing oesophagitis grade A or B in Los Angeles (LA) classification
* presence of typical symptoms of GERD (heartburn and ⁄or regurgitation with at least three episodes of typical symptoms per week in the absence of PPI therapy),
* adequate symptom relief obtained with PPIs,but needing maintenance with at least standard dose.

Exclusion Criteria

* presence of Barrett's oesophagus \>3 cm and ⁄or with dysplasia and ⁄or previously treated,
* presence of hiatus hernia \>3 cm,
* presence of oesophagitis grade C or D in LA classification,
* presence of oesophageal stricture or achalasia,
* history of oesophageal or gastric surgery,
* presence of gastric or oesophageal varices,
* impossibility to stop an anticoagulant therapy or severe coagulopathy,
* any contraindication to general anaesthesia.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No