Gastroesophageal Reflux DiseaseNCT01798212
Prospective Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
A study testing endoscopic full thickness plication in people with Gastroesophageal Reflux Disease, run by Krankenhaus Barmherzige Schwestern Linz at 2 sites in Austria.
Trial summary
A prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with GERD. The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom… 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?
- endoscopic full thickness plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesAustria
- Study dates
- Aug 2013to Dec 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent; ≥ 18 years of age;
- GERD documented by 24h ambulatory Multichannel Impedance-pH-Monitoring off antisecretory therapy and/or Gastroscopy by one or more of the following criteria:
- Total Number of Reflux Events ≥ 73/24h;
- DeMeester Score ≥ 14.7;
- Positive Symptom Index - SI ≥ 50% for Symptoms troublesome for the Patient with a Frequency of at least 3/24hrs; Macroendoscopically distinct mucosal breaks.
Who cannot join
- Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction;
- ≤ 18 years of age; Pregnancy and lactation; Previous extensive abdominal surgery; Previous esophageal or gastric surgery; Hiatal hernia >2cm; paraesophageal hernia; American Society of Anaesthesiologists physical status classification >II
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Krankenhaus Barmherzige Schwestern
Linz, 4010
Krankenhaus Zell am See
Zell am See, 5700
About this study
Official title: A Prospective Multi Center Case Controlled Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
A prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with GERD.
The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- endoscopic full thickness plication
- Keywords
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic full thickness plicationProcedure or surgery
Also called GERDx™
| Study group | Role | What they receive |
|---|---|---|
| full thickness gastroplication | Other | Not described Receives: Procedure: endoscopic full thickness plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life using the Gastrointestinal Quality of Life Index
Measured: change from baseline in Quality of Life at 3 months, one year and three years after the intervation
Secondary outcomes (2)
lower esophageal sphincter pressure using oesophageal manometry
Measured: change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion
DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment
Measured: change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798212
- Sponsor's protocol ID
- PlicatorLinz
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2013
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi Center Case Controlled Trial on the Clinical Feasibility of a New Full Thickness Endoscopic Plication Device for Patients With GERD.
- ClinicalTrials.gov ID
- NCT01798212
- Acronym / sponsor ID
- PlicatorLinz
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Feb 2013 (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.
A prospective multi center case controlled trial on the clinical feasibility of a new full thickness endoscopic plication device for patients with GERD.
The primary objective of the present trial is to investigate, clinical feasibility of the GERDx™ device, evaluating surgical aspects, quality of life, and symptom sores. Secondary objective of the trail is to evaluate objective data before and after the procedure, using manometry and 24h impedeance measurement
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| full thickness gastroplication | Other | Procedure: endoscopic full thickness plication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent; ≥ 18 years of age;
- GERD documented by 24h ambulatory Multichannel Impedance-pH-Monitoring off antisecretory therapy and/or Gastroscopy by one or more of the following criteria:
- Total Number of Reflux Events ≥ 73/24h;
- DeMeester Score ≥ 14.7;
- Positive Symptom Index - SI ≥ 50% for Symptoms troublesome for the Patient with a Frequency of at least 3/24hrs; Macroendoscopically distinct mucosal breaks.
Key exclusion criteria (2 listed)
- Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction;
- ≤ 18 years of age; Pregnancy and lactation; Previous extensive abdominal surgery; Previous esophageal or gastric surgery; Hiatal hernia >2cm; paraesophageal hernia; American Society of Anaesthesiologists physical status classification >II
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 |
|---|---|---|
| endoscopic full thickness plicationAlso: GERDx™ | Procedure or surgery | full thickness gastroplication |
Primary outcome
Quality of Life using the Gastrointestinal Quality of Life Index
Time frame: change from baseline in Quality of Life at 3 months, one year and three years after the intervation
2 secondary outcomes
lower esophageal sphincter pressure using oesophageal manometry
Time frame: change from baseline in lower esophageal sphincter pressure at 3 months, one year and 3 years after the intervantion
DeMeester score, number of reflux events using 24h-ph-Impedancemeasurment
Time frame: change from baseline in DeMeester score at 3 months, one year and 3 years after the intervantion
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 1 Mar 2017.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic full thickness plication in people with Gastroesophageal Reflux Disease, run by Krankenhaus Barmherzige Schwestern Linz at 2 sites 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 5 inclusion and 2 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Quality of Life using the Gastrointestinal Quality of Life Index (time frame: change from baseline in Quality of Life at 3 months, one year and three years after the intervation). 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 1 Mar 2017.