Gastro-esophageal RefluxARMANCT05425771
ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease
A study testing Anti Reflux Mucosa Ablation in people with Gastro-esophageal Reflux and Reflux, Gastroesophageal, run by Klinikum Garmisch-Patenkirchen at 1 site in Germany.
Trial summary
Pilot study of the possible clinical response to anti reflux mucosal ablation in patients with chronic refractory reflux disease Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastro-esophageal Reflux, Reflux, Gastroesophageal
- What is being tested?
- Anti Reflux Mucosa 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 siteGermany
- Study dates
- 14 Jul 2022to 31 May 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- typical reflux symptoms more than 2x per week during PPI therapy more than 6 month
- proof of gastro-esophageal reflux in pH metry oder pH/Impedance measurement
Who cannot join
- age < 18 y
- primary motility disorder of the esophagus
- hiatal hernia > 3 cm
- Hill classification > III
- pregnancy
- coagulation disorder
- mandatory intake of oral anticoagulation drugs
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Bavaria, 82467
About this study
Pilot study of the possible clinical response to anti reflux mucosal ablation in patients with chronic refractory reflux disease
Read the detailed description
Prospective, non-controlled, monocentric pilot study in patients with therapy-refractory reflux symptoms under proton pump inhibitor (PPI) therapy or intolerance of the necessary therapy or rapid recurrence of the symptoms with tapering therapy.
The symptoms must have existed for >6 months. Gastroesophageal reflux disease (GERD) must be diagnosed before inclusion in the study. This is the case if either erosive reflux esophagitis according to Los Angeles classification grades A-D is present or non-erosive reflux disease (NERD) has been confirmed by a 24-hour pH measurement/impedance measurement. The measurement must show either an increased number of reflux events or a prolonged time under reflux. In addition, there must be a high correlation between symptoms and reflux events when reporting symptom events. The GERD-HRQL score is queried for the clinical quantification of symptoms.
An esophageal motility disorder, especially achalasia or relevant hypomotility must be ruled out in an high resolution esophageal manometry. A relevant gastric emptying disorder is ruled out using a C13 octanoate breath test.
Patients with a Hill IV axial hernia, a paraesophageal hernia, or Barrett's esophagus are not included. Pregnancy must be ruled out in women of childbearing age.
The ARMA procedure is explained to the patient in detail with the expected benefits and risks in oral and written form. In addition, alternative treatments such as surgical fundoplication are discussed.
In the ARMA procedure, a gastroscopy is performed under sedation with propofol. Argon plasma coagulation (APC) is performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm, as described in the original publication. The intended destruction of the uppermost layer of the gastroesophageal junction is intended to induce an inflammatory reaction with subsequent shrinkage of the corresponding tissue section. This leads to a tightening of the gastroesophageal junction with subsequent improved tightness, so that reflux events occur less frequently.
Patients will be monitored in hospital for 48 hours. The existing drug therapy is continued for 4 weeks and then tapered off.
Endoscopic and clinical follow-up checks take place after 2 and 6 months using gastroscopy and GERD-HRQL score.
- Conditions
- Gastro-esophageal Reflux, Reflux, Gastroesophageal
- Being tested
- Anti Reflux Mucosa Ablation
- Keywords
- Reflux disease, Endoscopic therapy
- 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 Mucosa AblationProcedure or surgery
Mucosa ablation with Argon plasma coagulation performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm in patients with refractory reflux symptoms
| Study group | Role | What they receive |
|---|---|---|
| Mucosa Ablation Arm | Experimental | Treatment group Receives: Procedure: Anti Reflux Mucosa Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of GERD-HRQL
The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) is a standardized questionaire and a quantitative method of measuring symptom severity in gastroesophageal reflux disease (GERD). The results are from minimal 0 points up to 50 points. The higher the points, the greater the complaints.
Measured: Before and after 2 and 6 Month
Rate of major complications
Recording of all major complication which require hospitalization
Measured: day 1
Secondary outcomes (3)
Technical success nominal scale
In this case, the abortion of the procedure or the subjective assessment of the examiner apply immediately after the end of the procedure.
The examiner evaluates the complete technical success as successful or unsuccessful
Measured: Day 1
change of DeMeester Score
The DeMeester score is a scoring system at pH/Impendence measurement that quantifies esophageal acid exposure time in long-term pH monitoring. A DeMeester score of ≤ 14.72 is considered physiological.
The score includes the following values:
Percentage of time with esophageal pH < 4 of total measurement time Percentage of time with pH < 4 during the waking phase (upright position) Percentage of time with pH < 4 during the sleep phase (lying position) Total number of reflux episodes during the measurement time Number of reflux episodes lasting > 5 min Duration of the longest reflux episode
Measured: Before and after 2 and 6 Month
change of reflux events
Measurement of the number of events in the pH/Impendence measurement. A count <74 in 24 hours is considered normal.
Measured: Before and after 2 and 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start14 Jul 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (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.
- 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
- Sequential
- Model description
- Pilot study of mucosal ablation for therapy refractory reflux disease
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Garmisch-Patenkirchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425771
- Sponsor's protocol ID
- ARMA01
- Acronym
- ARMA
- Status last verified
- Jul 2022
- First submitted
- 28 Jan 2022
- Last updated
- 14 Jul 2022
- 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 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARMA (Antireflux Mucosa Ablation) in Patients With Chronic Refractory Reflux Disease
- ClinicalTrials.gov ID
- NCT05425771
- Acronym / sponsor ID
- ARMA / ARMA01
- Conditions
- Gastro-esophageal Reflux, Reflux, Gastroesophageal
- Keywords
- Reflux disease, Endoscopic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Klinikum Garmisch-PatenkirchenUniversity, hospital or other
- Study start
- 14 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 21 Jun 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.
Pilot study of the possible clinical response to anti reflux mucosal ablation in patients with chronic refractory reflux disease
Detailed description
Prospective, non-controlled, monocentric pilot study in patients with therapy-refractory reflux symptoms under proton pump inhibitor (PPI) therapy or intolerance of the necessary therapy or rapid recurrence of the symptoms with tapering therapy.
The symptoms must have existed for >6 months. Gastroesophageal reflux disease (GERD) must be diagnosed before inclusion in the study. This is the case if either erosive reflux esophagitis according to Los Angeles classification grades A-D is present or non-erosive reflux disease (NERD) has been confirmed by a 24-hour pH measurement/impedance measurement. The measurement must show either an increased number of reflux events or a prolonged time under reflux. In addition, there must be a high correlation between symptoms and reflux events when reporting symptom events. The GERD-HRQL score is queried for the clinical quantification of symptoms.
An esophageal motility disorder, especially achalasia or relevant hypomotility must be ruled out in an high resolution esophageal manometry. A relevant gastric emptying disorder is ruled out using a C13 octanoate breath test.
Patients with a Hill IV axial hernia, a paraesophageal hernia, or Barrett's esophagus are not included. Pregnancy must be ruled out in women of childbearing age.
The ARMA procedure is explained to the patient in detail with the expected benefits and risks in oral and written form. In addition, alternative treatments such as surgical fundoplication are discussed.
In the ARMA procedure, a gastroscopy is performed under sedation with propofol. Argon plasma coagulation (APC) is performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm, as described in the original publication. The intended destruction of the uppermost layer of the gastroesophageal junction is intended to induce an inflammatory reaction with subsequent shrinkage of the corresponding tissue section. This leads to a tightening of the gastroesophageal junction with subsequent improved tightness, so that reflux events occur less frequently.
Patients will be monitored in hospital for 48 hours. The existing drug therapy is continued for 4 weeks and then tapered off.
Endoscopic and clinical follow-up checks take place after 2 and 6 months using gastroscopy and GERD-HRQL score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study of mucosal ablation for therapy refractory reflux disease
| Arm | Type | Receives |
|---|---|---|
| Mucosa Ablation Arm | Experimental | Procedure: Anti Reflux Mucosa AblationTreatment group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- typical reflux symptoms more than 2x per week during PPI therapy more than 6 month
- proof of gastro-esophageal reflux in pH metry oder pH/Impedance measurement
Key exclusion criteria (7 listed)
- age < 18 y
- primary motility disorder of the esophagus
- hiatal hernia > 3 cm
- Hill classification > III
- pregnancy
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 Mucosa AblationMucosa ablation with Argon plasma coagulation performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm in patients with refractory reflux symptoms | Procedure or surgery | Mucosa Ablation Arm |
Primary outcome
change of GERD-HRQL
Time frame: Before and after 2 and 6 Month
The Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) is a standardized questionaire and a quantitative method of measuring symptom severity in gastroesophageal reflux disease (GERD). The results are from minimal 0 points up to 50 points. The higher the points, the greater the complaints.
Rate of major complications
Time frame: day 1
Recording of all major complication which require hospitalization
3 secondary outcomes
Technical success nominal scale
Time frame: Day 1
change of DeMeester Score
Time frame: Before and after 2 and 6 Month
change of reflux events
Time frame: Before and after 2 and 6 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mucosa Ablation in people with Gastro-esophageal Reflux and Reflux, Gastroesophageal, run by Klinikum Garmisch-Patenkirchen 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 2 inclusion and 7 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 14 Jul 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 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. 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?
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?
change of GERD-HRQL (time frame: Before and after 2 and 6 Month). 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 14 Jul 2022.