Radiofrequency Energy Delivery for Gastroesophageal Reflu... | NCT03223116

Studies
Radiofrequency Energy Delivery for Gastroesophageal Reflux Disease

NCT03223116

Sponsor

Changhai Hospital

Status

Unknown status

Last Update Posted

Jul 19, 2017Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Gastroesophageal Reflux Disease

Interventions

Radiofrequency delivery

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Sep 1, 2017Estimated

Completion Date

Jul 1, 2018Estimated

First Submitted Date

Jun 30, 2017

First Submission Date that Met QC Criteria

Jul 18, 2017

First Posted Date

Jul 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2017

Last Update Posted Date

Jul 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiofrequency	Experimental	Radiofrequency delivery to the gastroesophageal junction	Procedure: Radiofrequency delivery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiofrequency delivery	Procedure	Radiofrequency to the gastroesophageal junction	Radiofrequency

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline GERD-HRQL scores at 12 months	Assess the GERD-HRQL scores at 12 month and compare it with the baseline	12 months

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline esophagitis grade at 12 months	Assess the esophagitis condition at 12 month and compare it with the baseline	12 months
Change from baseline esophageal acid exposure times from at 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
luowei Wang, MD	Contact	13901833088		wangluoweimd@126.com
peipei Liu, MD	Contact	15821692703		15821692703@163.com

Overall Officials

Name	Affiliation	Role
zhaoshen Li, MD	Changhai Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departmentof Gastroenterology Changhai Hospital	Recruiting	Shanghai	Shanghai Municipality	200433	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27261337	Background	Fock KM, Talley N, Goh KL, Sugano K, Katelaris P, Holtmann G, Pandolfino JE, Sharma P, Ang TL, Hongo M, Wu J, Chen M, Choi MG, Law NM, Sheu BS, Zhang J, Ho KY, Sollano J, Rani AA, Kositchaiwat C, Bhatia S. Asia-Pacific consensus on the management of gastro-oesophageal reflux disease: an update focusing on refractory reflux disease and Barrett's oesophagus. Gut. 2016 Sep;65(9):1402-15. doi: 10.1136/gutjnl-2016-311715. Epub 2016 Jun 3.

ID	Term
D005764	Gastroesophageal Reflux
D006356	Heartburn

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases