Gastroesophageal RefluxNCT05259579
ARMA for Postoperative GERD After Sleeve Gastrectomy
A study testing Anti-reflux mucosal ablation in people with Gastroesophageal Reflux, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Anti-reflux mucosal ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2022to 31 Jul 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment
- Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% on pH study
Who cannot join
- Primary esophageal motility disorders
- Sliding hiatal hernia >3cm
- Narrow gastric sleeve that precludes retroflexion of scope
- Gastric sleeve stricture
- Malignancy
- Pregnancy
Show all 9Show fewer
- Patients not fit for general anesthesia
- Other cases deemed by the examining physician as unsuitable for safe treatment
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Stephen KK Ng, FRCSEd(Gen), +85235052956, stephenng@surgery.cuhk.edu.hk
Man Yee Yung, +85235052956, myyung@surgery.cuhk.edu.hk
About this study
Official title: Anti-reflux Mucosal Ablation (ARMA) for the Treatment of Postoperative Gastroesophageal Reflux After Sleeve Gastrectomy - A Pilot Study
This study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy
- Conditions
- Gastroesophageal Reflux
- Being tested
- Anti-reflux mucosal ablation
- 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 mucosal ablationProcedure or surgery
Also called ARMA
Mucosal ablation is planned around the cardia on the gastric side in a butterfly shape. Submucosal layer is raised by injecting saline with indigo carmine dye. Mucosal ablation is performed using the triangle-tip knife in spray coagulation mode.
| Study group | Role | What they receive |
|---|---|---|
| Anti-reflux mucosal ablation | Experimental | This technique creates an anti-reflux mechanism by performing mucosal ablation at the gastric cardia and inducing cicatrisation, and thereby rebuilds the flap valve at the gastric cardia Receives: Procedure: Anti-reflux mucosal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GERD symptoms
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score [0-75, higher scores mean worse outcome]
Measured: 3 and 6months
Change in GERD symptoms
astroesophageal Reflux Disease Questionnaire (GERDQ) score [0-18, higher scores mean worse outcome]
Measured: 3 and 6months
Secondary outcomes (6)
Technical success rate
defined as successful completion of endoscopic procedure
Measured: 1 day
Change in DeMeester score and AET
evaluated by 24-hour pH monitoring
Measured: 3 months
Dysphagia symptoms
evaluated by the Brief Esophageal Dysphagia Questionnaire (BEDQ) score [0-40, higher score mean worse outcome]
Measured: 3 and 6 months
PPI use
dosage of PPI use after procedure
Measured: 3 and 6 months
Changes in cardia morphology
endoscopic assessment of Hill's flap grade
Measured: 3 months
Adverse events rate relating to endoscopic intervention
complication including bleeding, perforation and stricture
Measured: 7 days, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 Feb 2022
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen K.K. Ng, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259579
- Sponsor's protocol ID
- CRE-2021.553
- Status last verified
- Feb 2022
- First submitted
- 26 Jan 2022
- Last updated
- 28 Feb 2022
- Results posted
- 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 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-reflux Mucosal Ablation (ARMA) for the Treatment of Postoperative Gastroesophageal Reflux After Sleeve Gastrectomy - A Pilot Study
- ClinicalTrials.gov ID
- NCT05259579
- Acronym / sponsor ID
- CRE-2021.553
- Conditions
- Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 28 Feb 2022 (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 study is a pilot trial designed to evaluate the safety and efficacy of endoscopic anti-reflux ablation in postoperative gastroesophageal reflux after sleeve gastrectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-reflux mucosal ablation | Experimental | Procedure: Anti-reflux mucosal ablationThis technique creates an anti-reflux mechanism by performing mucosal ablation at the gastric cardia and inducing cicatrisation, and thereby rebuilds the flap valve at the gastric cardia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with reflux symptoms after sleeve gastrectomy and are dependent on or refractory to PPI treatment
- Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% on pH study
Key exclusion criteria (9 listed)
- Primary esophageal motility disorders
- Sliding hiatal hernia >3cm
- Narrow gastric sleeve that precludes retroflexion of scope
- Gastric sleeve stricture
- Malignancy
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 mucosal ablationAlso: ARMAMucosal ablation is planned around the cardia on the gastric side in a butterfly shape. Submucosal layer is raised by injecting saline with indigo carmine dye. Mucosal ablation is performed using the triangle-tip knife in spray coagulation mode. | Procedure or surgery | Anti-reflux mucosal ablation |
Primary outcome
Change in GERD symptoms
Time frame: 3 and 6months
Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) questionnaire score [0-75, higher scores mean worse outcome]
Change in GERD symptoms
Time frame: 3 and 6months
astroesophageal Reflux Disease Questionnaire (GERDQ) score [0-18, higher scores mean worse outcome]
6 secondary outcomes
Technical success rate
Time frame: 1 day
Change in DeMeester score and AET
Time frame: 3 months
Dysphagia symptoms
Time frame: 3 and 6 months
PPI use
Time frame: 3 and 6 months
Changes in cardia morphology
Time frame: 3 months
Adverse events rate relating to endoscopic intervention
Time frame: 7 days, 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- 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 Anti-reflux mucosal ablation in people with Gastroesophageal 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 2 inclusion and 9 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 28 Feb 2022. 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 Stephen Ng, FRCSEd(Gen) (+85235052956, stephenng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GERD symptoms (time frame: 3 and 6months). The study lists 2 primary outcomes in all. 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 28 Feb 2022.