Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)

August 20, 2017 updated by: Ruihua Shi

Department of Gastroenterology, Zhongda Hospital

Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Full sufficiency in literacy
  2. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
  3. Refractory gastroesophageal reflux disease

Exclusion Criteria:

  1. Severe heart, lung, and cerebrovascular disease
  2. Severe hematopoietic system disease
  3. Abnormal blood coagulation function
  4. Oropharyngeal abnormalities
  5. Severe spine malformation
  6. In pregnancy and lactation at present, or plan to become pregnant within 2 years
  7. Severe inflammation or huge ulcers in stomach
  8. Mental and psychological disorde

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: completely circumferential ARMS
Procedure: anti-reflux mucosectomy
Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.
Other: semi-circumferential ARMS
Procedure: anti-reflux mucosectomy
Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of symptoms
Time Frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Improvement of all the symptoms related with RGERD.
1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of ARMS
Time Frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Complications of ARMS,such as esophageal stenosis and dysphagia.
1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruihua Shi

Investigators

  • Study Chair: Huiping Wang, Zhongda Hospital Southeast University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2017

Primary Completion (Anticipated)

November 20, 2017

Study Completion (Anticipated)

August 31, 2020

Study Registration Dates

First Submitted

August 20, 2017

First Submitted That Met QC Criteria

August 20, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 20, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GI of Zhongda

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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