Refractory Gastroesophageal Reflux DiseaseNCT03259191
Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)
A study testing anti-reflux mucosectomy in people with Refractory Gastroesophageal Reflux Disease, run by Ruihua Shi at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Refractory Gastroesophageal Reflux Disease
- What is being tested?
- anti-reflux mucosectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2017to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Full sufficiency in literacy
- Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
- Refractory gastroesophageal reflux disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Jiacheng Tan, 8615105165989, cencen_njjs@126.com
About this study
Official title: Department of Gastroenterology, Zhongda Hospital
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.
- Being tested
- anti-reflux mucosectomy
- Keywords
- Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-reflux mucosectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| completely circumferential ARMS | Other | Not described Receives: Procedure: anti-reflux mucosectomy |
| semi-circumferential ARMS | Other | Not described Receives: Procedure: anti-reflux mucosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of symptoms
Improvement of all the symptoms related with RGERD.
Measured: 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.
Measured: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start20 Aug 2017
- Primary completion20 Nov 2017 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruihua Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruihua Shi, Zhongda Hospital
- Investigators
- Huiping Wang, Study chair, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259191
- Sponsor's protocol ID
- GI of Zhongda
- Status last verified
- Aug 2017
- First submitted
- 20 Aug 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Gastroenterology, Zhongda Hospital
- ClinicalTrials.gov ID
- NCT03259191
- Acronym / sponsor ID
- GI of Zhongda
- Keywords
- Anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruihua ShiUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 20 Nov 2017 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| completely circumferential ARMS | Other | Procedure: anti-reflux mucosectomy |
| semi-circumferential ARMS | Other | Procedure: anti-reflux mucosectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Full sufficiency in literacy
- Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
- Refractory gastroesophageal reflux disease
Key exclusion criteria (8 listed)
- Severe heart, lung, and cerebrovascular disease
- Severe hematopoietic system disease
- Abnormal blood coagulation function
- Oropharyngeal abnormalities
- Severe spine malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-reflux mucosectomyAnti-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. | Procedure or surgery | completely circumferential ARMS, semi-circumferential ARMS |
Primary outcome
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.
1 secondary outcome
Complications of ARMS
Time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huiping Wang study chair
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-reflux mucosectomy in people with Refractory Gastroesophageal Reflux Disease, run by Ruihua Shi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruihua Shi, MD,PhD (+8613951799326, ruihuashi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of symptoms (time frame: 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.