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

Refractory Gastroesophageal Reflux Disease Clinical Trial

Official title:

Department of Gastroenterology, Zhongda Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03259191
• Other study ID #: GI of Zhongda
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2017
• Last updated: August 20, 2017
• Start date: August 20, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2017
• Source: Zhongda Hospital
• Contact: Ruihua Shi, MD,PhD
• Phone: +8613951799326
• Email: ruihuashi[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2020
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Refractory Gastroesophageal Reflux Disease

Intervention

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.

Locations

Country	Name	City	State
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Ruihua Shi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of symptoms	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	Complications of ARMS	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