Gastro Esophageal RefluxARMSNCT04194723
Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
A study testing Antireflux Mucosectomy in people with Gastro Esophageal Reflux, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- Antireflux Mucosectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2018to 31 Dec 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
- Hill's grade II and III of the gastroesophageal junction
- One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH < 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of < 6mmHg or total length of less than 4cm or abdominal length of less than 2cm
Who cannot join
- Age > 70 yrs of < 18 yrs
- Pregnancy
- Any type of Hiatus hernia
- Patients with underlying malignancy
- ASA above grade III
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, 00000
Philip Chiu, MD, 85226322627, philipchiu@surgery.cuhk.edu.hk
Man Yee Yung, +85235052956, myyung@surgery.cuhk.edu.hk
About this study
Official title: Phase II Clinical Study on the Safety and Efficacy of Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.
Read the detailed description
The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- Antireflux Mucosectomy
- Keywords
- Antireflux Mucosectomy, GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antireflux MucosectomyProcedure or surgery
ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux
| Study group | Role | What they receive |
|---|---|---|
| Antireflux Mucosectomy | Experimental | Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction Receives: Procedure: Antireflux Mucosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Gastro Esophageal Reflux symptoms
GERD symptoms evidence by the improvement in the Gastroesophageal Reflux Quality of Life (QoL) of ≥50% compared to the baseline off Proton Pump Inhibitors (PPI) value 3 months after the procedure
Measured: 3 months
Secondary outcomes (4)
Technical Success
Success in resection of mucosa at cardia by ARMS
Measured: 1 day
24 hour pH study post ARMS
24 hour pH study
Measured: 3 and 12 months
High resolution Manometry
HRM
Measured: 3 and 12 months
Gastroesophageal junction classified by Hill's classification
endoscopic assessment of Gastroesophageal junction
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Wai Yan CHIU, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194723
- Sponsor's protocol ID
- CREC 2016.194T
- Acronym
- ARMS
- Status last verified
- Nov 2023
- First submitted
- 10 Dec 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on the Safety and Efficacy of Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
- ClinicalTrials.gov ID
- NCT04194723
- Acronym / sponsor ID
- ARMS / CREC 2016.194T
- Conditions
- Gastro Esophageal Reflux
- Keywords
- Antireflux Mucosectomy, GERD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Dec 2019 (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.
This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.
Detailed description
The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antireflux Mucosectomy | Experimental | Procedure: Antireflux MucosectomyAntireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
- Hill's grade II and III of the gastroesophageal junction
- One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH < 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of < 6mmHg or total length of less than 4cm or abdominal length of less than 2cm
Key exclusion criteria (5 listed)
- Age > 70 yrs of < 18 yrs
- Pregnancy
- Any type of Hiatus hernia
- Patients with underlying malignancy
- ASA above grade III
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 |
|---|---|---|
| Antireflux MucosectomyARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux | Procedure or surgery | Antireflux Mucosectomy |
Primary outcome
Improvement in Gastro Esophageal Reflux symptoms
Time frame: 3 months
GERD symptoms evidence by the improvement in the Gastroesophageal Reflux Quality of Life (QoL) of ≥50% compared to the baseline off Proton Pump Inhibitors (PPI) value 3 months after the procedure
4 secondary outcomes
Technical Success
Time frame: 1 day
24 hour pH study post ARMS
Time frame: 3 and 12 months
High resolution Manometry
Time frame: 3 and 12 months
Gastroesophageal junction classified by Hill's classification
Time frame: 3 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antireflux Mucosectomy in people with Gastro Esophageal Reflux, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 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 7 Nov 2023. 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 Hong Kong. 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 Philip Wai Yan Chiu, MD, FRCSEd (+85235053952, philipchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Gastro Esophageal Reflux symptoms (time frame: 3 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 7 Nov 2023.