Atypical Gastroesophageal Reflux SymptomsNCT02181855
Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms
A study testing Full-thickness gastroplication (GERD-X) in people with Atypical Gastroesophageal Reflux Symptoms and Objectified Gastroesophageal Reflux Disease, run by Technical University of Munich at 4 sites in 2 countries.
Trial summary
Patients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example pH/MII). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atypical Gastroesophageal Reflux Symptoms, Objectified Gastroesophageal Reflux Disease
- What is being tested?
- Full-thickness gastroplication (GERD-X)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2014to Dec 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 years and 80 years
- symptomatic, objectified reflux disease (atypical symptoms - Montreal-classification)
Who cannot join
- Rejection of study-participation,
- Pregnancy
- negative pH-metry / impedance monitoring (non-objectified reflux)
- hiatal hernia bigger than 2 cm or gastroesophageal junction > Hill IV classification
- different potential reasons for atypical symptoms like heterotopic gastric mukosa in the cervikal esophagus
- Achalasia, esophageal spasm
- Presence of contraindications for the interventions
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites, 3 recruiting
- Recruiting
Klinikum Ludwigsburg, Klinik für Innere Medizin, Gastroenterologie, Hämato-Onkologie, Diabetologie und Infektiologie
Ludwigsburg, 71640
Karel Caca, Prof. Dr. med., +49 7141-99- ext. 67200, karel.caca@kliniken-lb.de
Arthur Schmidt, Dr. med., +49 7141-99- ext. 67200, Arthur.Schmidt@kliniken-lb.de
- Recruiting
Klinikum rechts der Isar der Technischen Universität München, II. Med. Klinik und Poliklinik
München, Bavaria, 81675
Simon Nennstiel, Dr. med., +49 89-4140 ext. 2251, simon.nennstiel@lrz.tum.de
Monther Bajbouj, PD Dr. med., +49 89-4140- ext. 2251, monther.bajbouj@lrz.tum.de
- Recruiting
Klinikum rechts der Isar der Technischen Universität München, Klinik und Poliklinik für Chirurgie
München, Bavaria, 81675
Hubertus Feußner, Prof. Dr. med., +49 89-4140- ext. 2139, hubertus.feussner@tum.de
Hubertus Feußner, Prof. Dr. med.
Austria1 site, 1 recruiting
- Not yet recruiting
Krankenhaus der Barmherzigen Schwestern Linz, Klinik für Allgemein- und Viszeralchirurgie
Linz, 4010
Georg Spaun, PD Dr. med., +43 732-7677- ext. 7300, georg.spaun@bhs.at
Oliver Koch, PD Dr. med., +43 732-7677- ext. 7300, oliver.owen.koch@gmail.com
About this study
Official title: Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms.
Patients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example pH/MII).
- Being tested
- Full-thickness gastroplication (GERD-X)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-thickness gastroplication (GERD-X)Procedure or surgery
Endoscopic full-thickness gastroplication wit the GERD-X device
| Study group | Role | What they receive |
|---|---|---|
| Atypical GERD syptoms treated with GERD-X | Other | Patients treated by means of full-thickness gastroplication Receives: Procedure: Full-thickness gastroplication (GERD-X) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflux Symptom index
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Gastroesophageal Reflux SymptomsStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monther Bajbouj, PD Dr. med., Principal investigator, Klinikum rechts der Isar, II. MedSimon Nennstiel, Dr. med., Principal investigator, Klinikum rechts der Isar, II. Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181855
- Sponsor's protocol ID
- atyGERD-X
- Status last verified
- Jan 2015
- First submitted
- 2 Jul 2014
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms.
- ClinicalTrials.gov ID
- NCT02181855
- Acronym / sponsor ID
- atyGERD-X
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 4 Jul 2014 (estimated)
- 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.
Patients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example pH/MII).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atypical GERD syptoms treated with GERD-X | Other | Procedure: Full-thickness gastroplication (GERD-X)Patients treated by means of full-thickness gastroplication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 years and 80 years
- symptomatic, objectified reflux disease (atypical symptoms - Montreal-classification)
Key exclusion criteria (7 listed)
- Rejection of study-participation,
- Pregnancy
- negative pH-metry / impedance monitoring (non-objectified reflux)
- hiatal hernia bigger than 2 cm or gastroesophageal junction > Hill IV classification
- different potential reasons for atypical symptoms like heterotopic gastric mukosa in the cervikal 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 |
|---|---|---|
| Full-thickness gastroplication (GERD-X)Endoscopic full-thickness gastroplication wit the GERD-X device | Procedure or surgery | Atypical GERD syptoms treated with GERD-X |
Primary outcome
Reflux Symptom index
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2015.
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.
Monther Bajbouj, PD Dr. med. principal investigator
Klinikum rechts der Isar, II. Med
Simon Nennstiel, Dr. med. principal investigator
Klinikum rechts der Isar, II. Med
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-thickness gastroplication (GERD-X) in people with Atypical Gastroesophageal Reflux Symptoms and Objectified Gastroesophageal Reflux Disease, run by Technical University of Munich at 4 sites in 2 countries.
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 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria. 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 Simon Nennstiel, Dr. med. (089-4140- ext. 2251, simon.nennstiel@lrz.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reflux Symptom index (time frame: 3 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 29 Jan 2015.