NCT03259191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

August 20, 2017

Last Update Submit

August 20, 2017

Conditions

Refractory Gastroesophageal Reflux Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Complications of ARMS

    1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months

Study Arms (2)

completely circumferential ARMS

OTHER
Procedure: anti-reflux mucosectomy

semi-circumferential ARMS

OTHER
Procedure: anti-reflux mucosectomy

Interventions

anti-reflux mucosectomyPROCEDURE

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.

completely circumferential ARMSsemi-circumferential ARMS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Huiping Wang

    Zhongda Hospital

    STUDY CHAIR

Central Study Contacts

Ruihua Shi, MD,PhD

CONTACT

+8613951799326ruihuashi@126.com

Jiacheng Tan, MD,PhD

CONTACT

+8615105165989cencen_njjs@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, Postdoctoral Mentor, Chief Physician

Study Record Dates

First Submitted

August 20, 2017

First Posted

August 23, 2017

Study Start

August 20, 2017

Primary Completion

November 20, 2017

Study Completion

August 31, 2020

Last Updated

August 23, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)