Gastroesophageal Reflux DiseaseNCT01453985
Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD
A study testing Full-Thickness-Gastroplication in people with Gastroesophageal Reflux Disease, run by General Public Hospital Zell am See at 1 site in Austria.
Trial summary
This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Full-Thickness-Gastroplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes >73.
Who cannot join
- any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia, esophageal strictures, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
General public hospital Zell am See
Zell am See, 5700
Oliver O Koch, MD, o.koch@sbg.at
Oliver O Koch, MD
About this study
This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Full-Thickness-Gastroplication
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-Thickness-GastroplicationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Full-Thickness-Gastroplication | Experimental | Not described Receives: Procedure: Full-Thickness-Gastroplication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
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 Gastroesophageal Reflux DiseaseStudies 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
Sponsor and investigators
- Lead sponsor
- General Public Hospital Zell am See
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453985
- Sponsor's protocol ID
- Zell04
- Status last verified
- Oct 2011
- First submitted
- 12 Oct 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
Publications
Koch OO, Kaindlstorfer A, Antoniou SA, Spaun G, Pointner R, Swanstrom LL. Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants. Gastrointest Endosc. 2013 Jan;77(1):7-14. doi: 10.1016/j.gie.2012.07.033. Epub 2012 Sep 26.
PubMed 23021166
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD
- ClinicalTrials.gov ID
- NCT01453985
- Acronym / sponsor ID
- Zell04
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- General Public Hospital Zell am SeeUniversity, hospital or other
- First posted
- 18 Oct 2011 (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.
This is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full-Thickness-Gastroplication | Experimental | Procedure: Full-Thickness-Gastroplication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes >73.
Key exclusion criteria (1 listed)
- any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia, esophageal strictures, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and 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 |
|---|---|---|
| Full-Thickness-Gastroplication | Procedure or surgery | Full-Thickness-Gastroplication |
Primary outcome
Quality of Life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2011.
- Derived from this study: PubMed 23021166Koch OO, Kaindlstorfer A, Antoniou SA, Spaun G, Pointner R, Swanstrom LL. Subjective and objective data on esophageal manometry and impedance pH monitoring 1 year after endoscopic full-thickness plication for the treatment of GERD by using multiple plication implants. Gastrointest Endosc. 2013 Jan;77(1):7-14. doi: 10.1016/j.gie.2012.07.033. Epub 2012 Sep 26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-Thickness-Gastroplication in people with Gastroesophageal Reflux Disease, run by General Public Hospital Zell am See at 1 site in Austria.
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 1 inclusion and 1 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 18 Oct 2011. 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 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 Rudolph Pointner, Prof. (004365427772210, ac.sekretariat@kh-zellamsee.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life. 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 NCT01453985, 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 Oct 2011.