GERDARMANCT04243668
ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
A study testing ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) in people with GERD, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD) DESIGN OF THE Prospective interventional study Sample size: 216 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD
- What is being tested?
- ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteIndia
- Study dates
- 2 Sep 2019to 30 Jun 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
- Patients who are willing to pay the expenses of the ARMA procedure
Who cannot join
- • Large Hiatal hernia >3cm
- Gr C/D esophagitis
- Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
Show all 10Show fewer
- Esophageal dysmotility
- ASA physical status >II
- Previous esophageal or gastric surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) FOR THE TREATMENT OF PROTON PUMP INHIBITOR DEPENDENT GASTRO ESOPHAGEALREFLUX DISEASE: OPEN LABEL SINGLE CENTER OBSERVATIONAL STUDY
OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD)
DESIGN OF THE Prospective interventional study Sample size: 216
Read the detailed description
In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.
Submucosal injection and elevation will not be used as a part of ARMA procedure for 10 patients amended protocol version 2.0
Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.
Inclusion criteria
- Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
- Patients who are willing to pay the expenses of the ARMA procedure
Exclusion criteria
- Large Hiatal hernia >3cm
- Gr C/D esophagitis
- Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
- Esophageal dysmotility
- ASA physical status >II
- Previous esophageal or gastric surgery
- Pregnancy
Patients screening and inclusion:
The study will be conducted over 6-months period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD HRQL and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal LES pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed.Those patients with pathologic esophageal acid exposure as described previously will be included in the trial. Patients will then be directly assigned by a computer to ARMA procedure. The principle investigator and the study coordinators would be open label to the treatment assignment.
- Conditions
- GERD
- Being tested
- ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)
- 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 ABLATION THERAPHY (ARMA)Procedure or surgery
In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.
Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| ANTI REFLUX MUCOSAL ABLATION THERAPHY | Experimental | In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. Receives: Procedure: ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months
Improvement in Gastroesophageal reflux disease symptoms by more than 50% from baseline at 3 months which would be assessed based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE
Measured: 3 months
Secondary outcomes (3)
requirement of PPI at 3, 6 and 12 months
requirement of Proton Pump Inhibitors at 3, 6 and 12 months based on GERD score evaluated based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE
Measured: requirement of PPI at 3, 6 and 12 months
Improvement in esophageal acid exposure
Improvement in esophageal acid exposure in PH impedence monitoring report from baseline
Measured: 6 months
Improvement in lower esophageal sphincter pressure at 3 months
Improvement in lower esophageal sphincter pressure at 3 months i.e sphincter pressure will be less compare to baseline pressure which will be known by the Esophageal manometry report.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start2 Sep 2019
- Primary completion2 Sep 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GERDStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rakesh Kalapala, Asian Institute of Gastroenterology, India
- Investigators
- Nageshwar Reddy, DNB, Principal investigator, Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243668
- Sponsor's protocol ID
- ARMA01
- Acronym
- ARMA
- Status last verified
- Dec 2023
- First submitted
- 7 Jan 2020
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koduri KK, Singla N, Maragoni RG, Jagtap N, Singh AP, Kalapala R, Reddy DN. Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months. Indian J Gastroenterol. 2025 Oct;44(5):700-707. doi: 10.1007/s12664-025-01761-z. Epub 2025 Jun 11.
PubMed 40498286
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOSCOPIC ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA) FOR THE TREATMENT OF PROTON PUMP INHIBITOR DEPENDENT GASTRO ESOPHAGEALREFLUX DISEASE: OPEN LABEL SINGLE CENTER OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT04243668
- Acronym / sponsor ID
- ARMA / ARMA01
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 2 Sep 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Jan 2020 (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.
OBJECTIVES To study the safety and efficacy of Endoscopic Anti Reflux Mucosal Ablation (ARMA) procedure for the treatment of proton pump inhibitor (PPI) dependent gastro-esophageal reflux disease (GERD)
DESIGN OF THE Prospective interventional study Sample size: 216
Detailed description
In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.
Submucosal injection and elevation will not be used as a part of ARMA procedure for 10 patients amended protocol version 2.0
Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire.
Inclusion criteria
- Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
- Patients who are willing to pay the expenses of the ARMA procedure
Exclusion criteria
- Large Hiatal hernia >3cm
- Gr C/D esophagitis
- Lower esophageal sphincter (LES) pressure<5 or >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
- Esophageal dysmotility
- ASA physical status >II
- Previous esophageal or gastric surgery
- Pregnancy
Patients screening and inclusion:
The study will be conducted over 6-months period. Data of patients presenting with PPI dependent GERD will be recorded and maintained. At initial screening, GERD HRQL and requirement of anti-secretory medicines (detailed drug history) will be assessed along with gastroscopy. All anti-secretory medicines will be stopped for 7 days and GERD HRQL will be reassessed off drugs. Esophageal high resolution manometry with 24-h pH impedance monitoring will be done on the 8th day after stopping medicines. Basal LES pressure, esophageal motility pattern, 24-h esophageal acid exposure, non acidic bolus reflux, number of reflux episodes, DeMeester score, symptom index and symptom association probability would be assessed.Those patients with pathologic esophageal acid exposure as described previously will be included in the trial. Patients will then be directly assigned by a computer to ARMA procedure. The principle investigator and the study coordinators would be open label to the treatment assignment.
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 THERAPHY | Experimental | Procedure: ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- • Patients (between 18 to 60 years of age) with PPI dependent GERD and pathologic esophageal acid exposure as documented by percentage time esophageal PH less than 4 of more than 4.2% on PH-metry during 24-hrs period while off PPI
Key exclusion criteria (10 listed)
- • Large Hiatal hernia >3cm
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 ABLATION THERAPHY (ARMA)In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min. Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire. | Procedure or surgery | ANTI REFLUX MUCOSAL ABLATION THERAPHY |
Primary outcome
Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months
Time frame: 3 months
Improvement in Gastroesophageal reflux disease symptoms by more than 50% from baseline at 3 months which would be assessed based on visual analog scale VAS 0 LOW SCORE 10 WORSE SYMPTOM SCORE
3 secondary outcomes
requirement of PPI at 3, 6 and 12 months
Time frame: requirement of PPI at 3, 6 and 12 months
Improvement in esophageal acid exposure
Time frame: 6 months
Improvement in lower esophageal sphincter pressure at 3 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 40498286Koduri KK, Singla N, Maragoni RG, Jagtap N, Singh AP, Kalapala R, Reddy DN. Efficacy and safety of anti-reflux mucosal ablation therapy at 12 months. Indian J Gastroenterol. 2025 Oct;44(5):700-707. doi: 10.1007/s12664-025-01761-z. Epub 2025 Jun 11.
- 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.
Nageshwar Reddy, DNB principal investigator
Chairman
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 THERAPHY (ARMA) in people with GERD, run by Asian Institute of Gastroenterology, India at 1 site in India.
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 10 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: finished, as of the sponsor's last update on 18 Dec 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04243668, which also lists 1 linked publication.
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 18 Dec 2023; AzTrials last refreshed its copy on 1 Nov 2026.