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Status unknownNCT03259191Updated Aug 23, 2017

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

An interventional study of anti-reflux mucosectomy in Refractory Gastroesophageal Reflux Disease, sponsored by Ruihua Shi. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2017-08-23.

Sponsored by Ruihua Shi · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Refractory Gastroesophageal Reflux Disease

Keywords

  • Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Other
    completely circumferential ARMS

    Procedure: anti-reflux mucosectomy

  • Other
    semi-circumferential ARMS

    Procedure: anti-reflux mucosectomy

Interventions

  • Procedureanti-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.

05

What researchers measure

Primary outcomes

  1. Improvement of symptoms

    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 outcomes

  1. Complications of ARMS

    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

06

Study locations

1 of 1 sites recruiting
  • Zhongda Hospital Southeast University
    Nanjing, Jiangsu, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03259191
Lead sponsor
Ruihua Shi
Responsible party
Ruihua Shi (MD, PhD, Postdoctoral Mentor, Chief Physician, Zhongda Hospital) — Sponsor-investigator
First posted
Aug 23, 2017
Start date
Aug 20, 2017
Primary completion
Nov 20, 2017 (estimated)
Completion
Aug 31, 2020 (estimated)
Last update
Aug 23, 2017

Study contacts

Ruihua Shi, MD,PhD
Contact
ruihuashi@126.com
+8613951799326
Jiacheng Tan, MD,PhD
Contact
cencen_njjs@126.com
+8615105165989
Huiping Wang
study chair · Zhongda Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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