Gastroesophageal RefluxAPDGNCT05763485
Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD
A study testing Anti reflux mucosal ablation (ARMA) in people with Gastroesophageal Reflux, run by Technical University of Munich at 1 site in Germany.
Trial summary
This is a prospective, randomized, single-blinded, interventional, controlled trial to evaluate the efficacy and safety of endoscopic anti reflux mucosal ablation (ARMA) in PPI dependent gastroesophageal reflux disease (GERD) in comparison to controls with a sham procedure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Anti reflux mucosal ablation (ARMA)
- 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 siteGermany
- Study dates
- 1 Mar 2023to 1 Mar 2025
- 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
- PPI dependent GERD for at least 6 months
- Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% in pH metry while off PPI
- Exclusion of primary esophageal motility disorders by manometry
- Upper endoscopy with biopsy (Exclusion of eosinophilic esophagitis)
Who cannot join
- Sliding hiatal hernia >3cm
- Los Angeles grade C/D esophagitis
- Primary esophageal motility disorders
- Grade IV Hill´s flap valve
- Pregnancy or planed pregnancy in the next 12 months
- Eosinophilic esophagitis
Show all 13Show fewer
- Paraesophageal hernia
- Previous esophageal or gastric surgery
- Barretts esophagus
- Liver cirrhosis
- Varices
- Lack of consent
- ASA physical status >III
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
Mohamed Abdelhafez, MD, +49894140 ext. 9320, mohamed.abdelhafez@tum.de
Rami Abbassi, MD, 08941409349, rami.abbassi@mri.tum.de
About this study
Official title: Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD: a Prospective Randomized, Single-blinded, Sham-controlled Trial
This is a prospective, randomized, single-blinded, interventional, controlled trial to evaluate the efficacy and safety of endoscopic anti reflux mucosal ablation (ARMA) in PPI dependent gastroesophageal reflux disease (GERD) in comparison to controls with a sham procedure.
Read the detailed description
Patients who fulfill the inclusion criteria and, after informed consent, are willing to participate in this study will be prepared for ARMA. After sedation the patients will be randomized equally into an intervention and control Group. The patients are blinded to the procedure. The Patients in the intervention group receive ARMA using argon plasma coagulation (APC) at the gastroesophageal junction (EGJ) in two semicircular patterns while the control group receives a sham procedure. The approximate duration of the procedure is 30min. After the procedure the patients receive follow up controls at 2, 4, 6 and 12 months. During the first follow up, 2 months after the procedure symptoms are evaluated by questionnaires (GERD- HRQL, FSSG, VAG). Subsequently the PPI- medication is stopped in all patients until the end of the study or worsening of symptoms. During the second follow up 4 months after the initial procedure the symptoms are reevaluated by questionnaires. The patients are then unblinded and are told if they received ARMA or sham procedure. Those patients who received ARMA are examined by esophagogastroduodenoscopy, esophageal manometry and pH metry. Further assessments is performed by questionnaires 6 and 12 months after the initial procedure.
Those patients in the control group are allowed to take part in a crossover to receive the ARMA procedure as well. If they receive ARMA, symptoms are reevaluated 2 months after the procedure by questionnaires, esophagogastroduodenoscopy, esophageal manometry and pH metry. Further controls are performed after 4, 6 and 12 months by questionnaires.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Anti reflux mucosal ablation (ARMA), Sham procedure
- Keywords
- anti reflux mucosal ablation, 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 (ARMA)Procedure or surgery
In patients fulfilling the inclusion criteria and being randomized for ARMA, the procedure using argon plasma coagulation involves two semicircular ablations of the mucosa of the EGJ in a butterfly shape of a width of 2 cm. The approximate duration of the procedure is 30min.
Follow includes objective evaluation of reflux disease by reflux questionnaires, esophagogastroduodenoscopy, esophageal manometry, pH metry.
Sham procedureProcedure or surgery
In patients fulfilling the inclusion criteria and being randomized for sham procedure, the procedure involves esophagogastroduodenoscopy with the same set of movements and duration as the ARMA procedure without the actual ablation.
| Study group | Role | What they receive |
|---|---|---|
| Anti reflux mucosal ablation (ARMA) | Active comparator | Patients randomized into the intervention arm receive ARMA and a follow up control after 2, 4, 6 and 12 months. PPI treatment is stopped after 2 months until the end of the study or worsening of symptoms. Esophagogastroduodenoscopy, manometry and pH metry is performed after 4 months. Receives: Procedure: Anti reflux mucosal ablation (ARMA) |
| Sham procedure | Sham comparator | Patients randomized into the sham procedure arm receive a esophagogastroduodenoscopy in the same setting as if ARMA would be performed. Patients in the Control group receive follow up controls after 2 and 4 months and after unblinding after 4 months are allowed to perform a crossover to receive ARMA. PPI treatment is stopped 2 months after the initial sham procedure until the end of the study or worsening of symptoms. If the patients receive ARMA as a crossover reevaluation is performed 2, 4, 6 and 12 months after the actual ARMA procedure. Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in symptoms of gastro esophageal reflux disease
Improvement in symptoms of gastro esophageal reflux disease by more than 50% from baseline in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 4 months after procedure. Total score 0-50; higher scores indicate greater complaints.
Measured: 4 months
Secondary outcomes (11)
Change in symptoms of gastro esophageal reflux disease
Change in symptoms of gastro esophageal reflux disease in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 6 and 12 months. Total score 0-50; higher scores indicate greater complaints.
Measured: 12 months
Change in symptoms of gastro esophageal reflux disease
Change in symptoms of gastro esophageal reflux disease in regurgitation score at 4, 6 and 12 months. Total score 0-30; higher scores indicate greater complaints.
Measured: 12 months
Change in symptoms of gastro esophageal reflux disease
Change in symptoms of gastro esophageal reflux disease in Frequency scale for the symptoms of GERD (FSSG) at 4, 6 and 12 months. Total score 0-48; higher scores indicate greater complaints.
Measured: 12 months
Change in symptoms of gastro esophageal reflux disease
Change in symptoms of gastro esophageal reflux disease in visual analog scale (VAS) at 4, 6 and 12 months. Total score 0-10; higher scores indicate greater complaints.
Measured: 12 months
Complication rate
Recording of all complications in relation to the ARMA- procedure
Measured: 12 months
PPI dependency
Requirement and dose of PPI at 4, 6 and 12 months
Measured: 12 months
Change in esophageal acid exposure at 4 months after ARMA
Change in esophageal acid exposure in pH metry 4 months after ARMA
Measured: 4 months after ARMA
Change in lower esophageal sphincter pressure 4 months after ARMA
Change in lower esophageal sphincter pressure in manometry 4 months after ARMA
Measured: 4 months after ARMA
Postinterventional pain
Recording of postinterventional pain in visual analog scale (VAS). Higher scores indicate greater complaints.
Measured: 1day
Changes in cardia morphology
Changes in Hill's flap grade
Measured: 4 months after ARMA
Technical success rate
Successful completion of ARMA
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (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 Technical University of MunichThe 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
- 4 months after the initial procedure (ARMA or sham-procedure) patients are unblinded. Patients who initially received the sham procedure are now allowed to be treated by ARMA.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelhafez, Technical University of Munich
- Investigators
- Mohamed Abdelhafez, MD, Principal investigator, Universitiy Hospital Rechts der Isar, Technical Universitiy Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763485
- Sponsor's protocol ID
- R0001
- Acronym
- APDG
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2023
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti Reflux Mucosal Ablation Therapy in PPI Dependent GERD: a Prospective Randomized, Single-blinded, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05763485
- Acronym / sponsor ID
- APDG / R0001
- Conditions
- Gastroesophageal Reflux
- Keywords
- anti reflux mucosal ablation, ARMA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Mar 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.
This is a prospective, randomized, single-blinded, interventional, controlled trial to evaluate the efficacy and safety of endoscopic anti reflux mucosal ablation (ARMA) in PPI dependent gastroesophageal reflux disease (GERD) in comparison to controls with a sham procedure.
Detailed description
Patients who fulfill the inclusion criteria and, after informed consent, are willing to participate in this study will be prepared for ARMA. After sedation the patients will be randomized equally into an intervention and control Group. The patients are blinded to the procedure. The Patients in the intervention group receive ARMA using argon plasma coagulation (APC) at the gastroesophageal junction (EGJ) in two semicircular patterns while the control group receives a sham procedure. The approximate duration of the procedure is 30min. After the procedure the patients receive follow up controls at 2, 4, 6 and 12 months. During the first follow up, 2 months after the procedure symptoms are evaluated by questionnaires (GERD- HRQL, FSSG, VAG). Subsequently the PPI- medication is stopped in all patients until the end of the study or worsening of symptoms. During the second follow up 4 months after the initial procedure the symptoms are reevaluated by questionnaires. The patients are then unblinded and are told if they received ARMA or sham procedure. Those patients who received ARMA are examined by esophagogastroduodenoscopy, esophageal manometry and pH metry. Further assessments is performed by questionnaires 6 and 12 months after the initial procedure.
Those patients in the control group are allowed to take part in a crossover to receive the ARMA procedure as well. If they receive ARMA, symptoms are reevaluated 2 months after the procedure by questionnaires, esophagogastroduodenoscopy, esophageal manometry and pH metry. Further controls are performed after 4, 6 and 12 months by questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 4 months after the initial procedure (ARMA or sham-procedure) patients are unblinded. Patients who initially received the sham procedure are now allowed to be treated by ARMA.
| Arm | Type | Receives |
|---|---|---|
| Anti reflux mucosal ablation (ARMA) | Active comparator | Procedure: Anti reflux mucosal ablation (ARMA)Patients randomized into the intervention arm receive ARMA and a follow up control after 2, 4, 6 and 12 months. PPI treatment is stopped after 2 months until the end of the study or worsening of symptoms. Esophagogastroduodenoscopy, manometry and pH metry is performed after 4 months. |
| Sham procedure | Sham comparator | Procedure: Sham procedurePatients randomized into the sham procedure arm receive a esophagogastroduodenoscopy in the same setting as if ARMA would be performed. Patients in the Control group receive follow up controls after 2 and 4 months and after unblinding after 4 months are allowed to perform a crossover to receive ARMA. PPI treatment is stopped 2 months after the initial sham procedure until the end of the study or worsening of symptoms. If the patients receive ARMA as a crossover reevaluation is performed 2, 4, 6 and 12 months after the actual ARMA procedure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PPI dependent GERD for at least 6 months
- Pathological esophageal acid exposure, defined by DeMeester score >14.7 or acid exposure time (AET) >4.2% in pH metry while off PPI
- Exclusion of primary esophageal motility disorders by manometry
- Upper endoscopy with biopsy (Exclusion of eosinophilic esophagitis)
Key exclusion criteria (13 listed)
- Sliding hiatal hernia >3cm
- Los Angeles grade C/D esophagitis
- Primary esophageal motility disorders
- Grade IV Hill´s flap valve
- Pregnancy or planed pregnancy in the next 12 months
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 (ARMA)In patients fulfilling the inclusion criteria and being randomized for ARMA, the procedure using argon plasma coagulation involves two semicircular ablations of the mucosa of the EGJ in a butterfly shape of a width of 2 cm. The approximate duration of the procedure is 30min. Follow includes objective evaluation of reflux disease by reflux questionnaires, esophagogastroduodenoscopy, esophageal manometry, pH metry. | Procedure or surgery | Anti reflux mucosal ablation (ARMA) |
| Sham procedureIn patients fulfilling the inclusion criteria and being randomized for sham procedure, the procedure involves esophagogastroduodenoscopy with the same set of movements and duration as the ARMA procedure without the actual ablation. | Procedure or surgery | Sham procedure |
Primary outcome
Improvement in symptoms of gastro esophageal reflux disease
Time frame: 4 months
Improvement in symptoms of gastro esophageal reflux disease by more than 50% from baseline in GERD-Health Related Quality of Life Questionnaire (GERD- HRQL) at 4 months after procedure. Total score 0-50; higher scores indicate greater complaints.
11 secondary outcomes
Change in symptoms of gastro esophageal reflux disease
Time frame: 12 months
Change in symptoms of gastro esophageal reflux disease
Time frame: 12 months
Change in symptoms of gastro esophageal reflux disease
Time frame: 12 months
Change in symptoms of gastro esophageal reflux disease
Time frame: 12 months
Complication rate
Time frame: 12 months
PPI dependency
Time frame: 12 months
Change in esophageal acid exposure at 4 months after ARMA
Time frame: 4 months after ARMA
Change in lower esophageal sphincter pressure 4 months after ARMA
Time frame: 4 months after ARMA
Postinterventional pain
Time frame: 1day
Changes in cardia morphology
Time frame: 4 months after ARMA
Technical success rate
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- 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.
Mohamed Abdelhafez, MD principal investigator
Universitiy Hospital Rechts der Isar, Technical Universitiy Munich
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 (ARMA) in people with Gastroesophageal Reflux, run by Technical University of Munich at 1 site in Germany.
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 4 inclusion and 13 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 10 Mar 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdelhafez, MD (08941409320, Mohamed.Abdelhafez@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in symptoms of gastro esophageal reflux disease (time frame: 4 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 10 Mar 2023.