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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259191
Recruitment Status : Unknown
Verified August 2017 by Ruihua Shi, Zhongda Hospital.
Recruitment status was:  Recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Ruihua Shi, Zhongda Hospital

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.

Condition or disease Intervention/treatment Phase
Refractory Gastroesophageal Reflux Disease Procedure: anti-reflux mucosectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Department of Gastroenterology, Zhongda Hospital
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : November 20, 2017
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259191


Contacts
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Contact: Ruihua Shi, MD,PhD +8613951799326 ruihuashi@126.com
Contact: Jiacheng Tan, MD,PhD +8615105165989 cencen_njjs@126.com

Locations
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China, Jiangsu
Zhongda Hospital Southeast University Recruiting
Nanjing, Jiangsu, China
Contact: Jiacheng Tan    8615105165989    cencen_njjs@126.com   
Sponsors and Collaborators
Ruihua Shi
Investigators
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Study Chair: Huiping Wang Zhongda Hospital Southeast University
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Responsible Party: Ruihua Shi, MD, PhD, Postdoctoral Mentor, Chief Physician, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT03259191    
Other Study ID Numbers: GI of Zhongda
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ruihua Shi, Zhongda Hospital:
Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases