NCT03223116

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

2.2 years

First QC Date

June 30, 2017

Last Update Submit

July 18, 2017

Conditions

Gastroesophageal Reflux Disease

Keywords

heartburnregurgitation

Outcome Measures

Primary Outcomes (1)

  • 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 (4)

  • Change from baseline esophagitis grade at 12 months

    12 months

  • Change from baseline esophageal acid exposure times from at 12 months

    12 month

  • Change from baseline lower esophageal sphincter pressure at 12 months

    12 month

  • Change from baseline medication at 12 months

    12 months

Study Arms (1)

Radiofrequency

EXPERIMENTAL

Radiofrequency delivery to the gastroesophageal junction

Procedure: Radiofrequency delivery

Interventions

Radiofrequency deliveryPROCEDURE

Radiofrequency to the gastroesophageal junction

Radiofrequency

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • diagnosis of GERD established by either
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departmentof Gastroenterology Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27261337BACKGROUND

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburn

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • zhaoshen Li, MD

    Changhai Hospital

    STUDY CHAIR

Central Study Contacts

luowei Wang, MD

CONTACT

13901833088wangluoweimd@126.com

peipei Liu, MD

CONTACT

1582169270315821692703@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Department of Gastroenterology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 19, 2017

Study Start

July 1, 2015

Primary Completion

September 1, 2017

Study Completion

July 1, 2018

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

CN(1)