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

Primary Purpose

Refractory Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anti-reflux mucosectomy
Sponsored by
Ruihua Shi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Gastroesophageal Reflux Disease focused on measuring Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhongda Hospital Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

completely circumferential ARMS

semi-circumferential ARMS

Arm Description

Outcomes

Primary Outcome Measures

Improvement of symptoms
Improvement of all the symptoms related with RGERD.

Secondary Outcome Measures

Complications of ARMS
Complications of ARMS,such as esophageal stenosis and dysphagia.

Full Information

First Posted
August 20, 2017
Last Updated
August 20, 2017
Sponsor
Ruihua Shi
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1. Study Identification

Unique Protocol Identification Number
NCT03259191
Brief Title
Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)
Official Title
Department of Gastroenterology, Zhongda Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ruihua Shi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Gastroesophageal Reflux Disease
Keywords
Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
completely circumferential ARMS
Arm Type
Other
Arm Title
semi-circumferential ARMS
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
anti-reflux mucosectomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of symptoms
Description
Improvement of all the symptoms related with RGERD.
Time Frame
1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Secondary Outcome Measure Information:
Title
Complications of ARMS
Description
Complications of ARMS,such as esophageal stenosis and dysphagia.
Time Frame
1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Full sufficiency in literacy Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks Refractory gastroesophageal reflux disease Exclusion Criteria: Severe heart, lung, and cerebrovascular disease Severe hematopoietic system disease Abnormal blood coagulation function Oropharyngeal abnormalities Severe spine malformation In pregnancy and lactation at present, or plan to become pregnant within 2 years Severe inflammation or huge ulcers in stomach Mental and psychological disorde
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruihua Shi, MD,PhD
Phone
+8613951799326
Email
ruihuashi@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiacheng Tan, MD,PhD
Phone
+8615105165989
Email
cencen_njjs@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiping Wang
Organizational Affiliation
Zhongda Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiacheng Tan
Phone
8615105165989
Email
cencen_njjs@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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