GERDNCT05899491
Role of ARMA in Selective Subset of Refractory GERD Patients.
A study testing ARMA and UGI Endoscopy in people with GERD and Reflux, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor). Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- GERD, Reflux, Reflux Esophagitis
- What is being tested?
- ARMA and UGI Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 30 Mar 2023to 30 Dec 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal Upper Gastrointestinal endoscopy And
- 24 hour pH Impedance: AET < 6%, More than 80 refluxes
- Patients who are willing to give consent for the procedure
Who cannot join
- Large Hiatal hernia >3cm
- Lower esophageal sphincter (LES) pressure >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
- Esophageal dysmotility
Show all 9Show fewer
- ASA physical status >II
- Previous esophageal or gastric surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
India1 site
Asian institute of Gastroenterology, hyderabad, India
Hyderabad, Telangana, 500032
About this study
Official title: Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.
To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).
Read the detailed description
Patients coming with symptoms of Gastroesophageal reflux disease (GERD) - A digestive disease in which stomach acid or bile irritates the food pipe lining, will be screened for eligibility and informed written consent will be taken. At initial screening, score based on clinical symptoms i.e. Gastroesophageal Reflux Disease- Quality of Life score (GERD HRQL) \& Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease Questionnaire (FSSG) score will be completed. All patients will undergo esophagogastroscopy (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract). to look for reflux (the backward flow of stomach acid into the tube that connects your throat to your stomach (esophagus)) related changes in the esophagus.
Esophageal high-resolution Manometry (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done to measure the various parameters which help doctor understand your disease.
24-hr pH impedance (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done after stopping anti-secretory medicines (medicines for the long-term treatment of GERD) for atleast three days to assess for esophageal parameters.
All patients will be divided randomly into two arms, ARMA and sham. Those in the ARMA arm will receive ARMA procedure, while patients in the sham arm will receive only upper gastrointestinal endoscopy.
- Conditions
- GERD, Reflux, Reflux Esophagitis
- Being tested
- ARMA, UGI Endoscopy
- Medical subject headings
- Gastroesophageal Reflux, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARMAProcedure or surgery
Patients will be instructed to fast for 6 hours pre-ARMA, the Procedure will be performed under propofol-based sedation. Patients will be in the left lateral decubitus position. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view.
UGI EndoscopyProcedure or surgery
UGI Endoscopy will be performed under propofol based sedation with scope kept inside for atleast 5 minutes.
Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry, reflux questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| ARMA Group | Active comparator | All patients in this group will undergo Anti-reflux mucosal ablation using upper gastrointestinal endoscopy. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view. Receives: Procedure: ARMA |
| Sham Group | Sham comparator | UGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes. Receives: Procedure: UGI Endoscopy |
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: One Year
Secondary outcomes (1)
Improvement in esophageal acid exposure
Improvement in esophageal acid exposure in PH impedence monitoring report from baseline.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start30 Mar 2023
- Primary completion30 Sep 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- A Randomized Sham Control Trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeraj Singla, MD, Principal investigator, Asian Institute of Gastroenterology, HyderabadDigvijay Chavan, Study chair, Asian Institute of Gastroenterology, Hyderabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899491
- Sponsor's protocol ID
- ARMA
- Status last verified
- Jun 2023
- First submitted
- 1 Apr 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Inoue H, Tanabe M, de Santiago ER, Abad MRA, Shimamura Y, Fujiyoshi Y, Ueno A, Sumi K, Tomida H, Iwaya Y, Ikeda H, Onimaru M. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open. 2020 Feb;8(2):E133-E138. doi: 10.1055/a-1031-9436. Epub 2020 Jan 22.
PubMed 32010745Chou CK, Chen CC, Chen CC, Wu JF, Liao WC, Chiu HM, Wang HP, Wu MS, Tseng PH. Positive and negative impact of anti-reflux mucosal intervention on gastroesophageal reflux disease. Surg Endosc. 2023 Feb;37(2):1060-1069. doi: 10.1007/s00464-022-09605-z. Epub 2022 Sep 15.
PubMed 36109362Rodriguez de Santiago E, Albeniz E, Estremera-Arevalo F, Teruel Sanchez-Vegazo C, Lorenzo-Zuniga V. Endoscopic anti-reflux therapy for gastroesophageal reflux disease. World J Gastroenterol. 2021 Oct 21;27(39):6601-6614. doi: 10.3748/wjg.v27.i39.6601.
PubMed 34754155
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of ARMA in Selective Subset of Refractory GERD Patients- A Randomized Sham Control Trial.
- ClinicalTrials.gov ID
- NCT05899491
- Acronym / sponsor ID
- ARMA
- Conditions
- GERD, Reflux, Reflux Esophagitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 12 Jun 2023 (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.
To study the role of a novel endoscopic treatment technique (ARMA) in GERD patients who doesn't respond to PPI therapy (Proton Pump Inhibitor).
Detailed description
Patients coming with symptoms of Gastroesophageal reflux disease (GERD) - A digestive disease in which stomach acid or bile irritates the food pipe lining, will be screened for eligibility and informed written consent will be taken. At initial screening, score based on clinical symptoms i.e. Gastroesophageal Reflux Disease- Quality of Life score (GERD HRQL) \& Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease Questionnaire (FSSG) score will be completed. All patients will undergo esophagogastroscopy (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract). to look for reflux (the backward flow of stomach acid into the tube that connects your throat to your stomach (esophagus)) related changes in the esophagus.
Esophageal high-resolution Manometry (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done to measure the various parameters which help doctor understand your disease.
24-hr pH impedance (procedure to diagnose and treat problems in your upper GI (gastrointestinal) tract) will be done after stopping anti-secretory medicines (medicines for the long-term treatment of GERD) for atleast three days to assess for esophageal parameters.
All patients will be divided randomly into two arms, ARMA and sham. Those in the ARMA arm will receive ARMA procedure, while patients in the sham arm will receive only upper gastrointestinal endoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Sham Control Trial
| Arm | Type | Receives |
|---|---|---|
| ARMA Group | Active comparator | Procedure: ARMAAll patients in this group will undergo Anti-reflux mucosal ablation using upper gastrointestinal endoscopy. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view. |
| Sham Group | Sham comparator | Procedure: UGI EndoscopyUGI Endoscopy will be performed under Propofol based sedation with scope kept inside for at least 5 minutes. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal Upper Gastrointestinal endoscopy And
- 24 hour pH Impedance: AET < 6%, More than 80 refluxes
- Patients who are willing to give consent for the procedure
Key exclusion criteria (9 listed)
- Large Hiatal hernia >3cm
- Lower esophageal sphincter (LES) pressure >15 mm Hg
- Paraesophageal hernia
- GE flap valve grade IV (Hill's classification)
- Barretts esophagus
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 |
|---|---|---|
| ARMAPatients will be instructed to fast for 6 hours pre-ARMA, the Procedure will be performed under propofol-based sedation. Patients will be in the left lateral decubitus position. The stomach will be insufflated with CO2 to visualize the cardia in retroflex view. | Procedure or surgery | ARMA Group |
| UGI EndoscopyUGI Endoscopy will be performed under propofol based sedation with scope kept inside for atleast 5 minutes. Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry, reflux questionnaire. | Procedure or surgery | Sham Group |
Primary outcome
Improvement in Gastro esophageal reflux disease symptoms by more than 50% from baseline at 3 months.
Time frame: One Year
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.
1 secondary outcome
Improvement in esophageal acid exposure
Time frame: One Year
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 4 Apr 2025.
- Results publication: PubMed 32010745Inoue H, Tanabe M, de Santiago ER, Abad MRA, Shimamura Y, Fujiyoshi Y, Ueno A, Sumi K, Tomida H, Iwaya Y, Ikeda H, Onimaru M. Anti-reflux mucosal ablation (ARMA) as a new treatment for gastroesophageal reflux refractory to proton pump inhibitors: a pilot study. Endosc Int Open. 2020 Feb;8(2):E133-E138. doi: 10.1055/a-1031-9436. Epub 2020 Jan 22.
- Results publication: PubMed 36109362Chou CK, Chen CC, Chen CC, Wu JF, Liao WC, Chiu HM, Wang HP, Wu MS, Tseng PH. Positive and negative impact of anti-reflux mucosal intervention on gastroesophageal reflux disease. Surg Endosc. 2023 Feb;37(2):1060-1069. doi: 10.1007/s00464-022-09605-z. Epub 2022 Sep 15.
- Results publication: PubMed 34754155Rodriguez de Santiago E, Albeniz E, Estremera-Arevalo F, Teruel Sanchez-Vegazo C, Lorenzo-Zuniga V. Endoscopic anti-reflux therapy for gastroesophageal reflux disease. World J Gastroenterol. 2021 Oct 21;27(39):6601-6614. doi: 10.3748/wjg.v27.i39.6601.
- 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.
Neeraj Singla, MD principal investigator
Asian Institute of Gastroenterology, Hyderabad
Digvijay Chavan study chair
Asian Institute of Gastroenterology, Hyderabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARMA and UGI Endoscopy in people with GERD and Reflux, 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 3 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: finished, as of the sponsor's last update on 4 Apr 2025. 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. Some participants in this study may receive a placebo. 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: One Year). 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 NCT05899491, which also lists 3 linked publications.
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 4 Apr 2025.