Globus Sensations in the ThroatACHAT FUNCT01574755
Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations
An observational study of Globus Sensations in the Throat, run by Technical University of Munich.
Trial summary
APC of gastric inlet patches is successful for the treatment of globus sensations in the throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term efficiency of this treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Globus Sensations in the Throat
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Feb 2012
- Phase
- Observational
- 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
Study population: outpatient clinic of a university hospital
Who may be able to join
- former APC therapy of gastric inlet patches as treatment for globus sensations
- at least 6 month since last APC therapy
Who cannot join
- patients with reduced general condition
- malignancy of the upper gastrointestinal tract
- patients older than 80 years
About this study
APC of gastric inlet patches is successful for the treatment of globus sensations in the throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term efficiency of this treatment. To measure long term efficacy all patients treated with this therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.
- Conditions
- Globus Sensations in the Throat
- Keywords
- gastric inlet patches, argon plasma coagulation, globus sensations
- Medical subject headings
- Globus Sensation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of globus complaint score
Measured: retrospectively assessed: before APC therapy and at the date of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Globus Sensations in the ThroatStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Klare, MD, Principal investigator, Departmet for Internal Medicine and Gastroenterology, Technical University Munich, GermanyAlexander Meining, Professor, Study chair, Department for Internal Medicine and Gastroenterology, Technical University Munich, GermanyMonther Bajbouj, Assistent Professor, Study director, Department for Internal Medicine and Gastroenterology, Technical University Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574755
- Sponsor's protocol ID
- ACHAT-FU-1
- Acronym
- ACHAT FU
- Status last verified
- Jun 2013
- First submitted
- 6 Apr 2012
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations
- ClinicalTrials.gov ID
- NCT01574755
- Acronym / sponsor ID
- ACHAT FU / ACHAT-FU-1
- Conditions
- Globus Sensations in the Throat
- Keywords
- gastric inlet patches, argon plasma coagulation, globus sensations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Apr 2012 (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.
APC of gastric inlet patches is successful for the treatment of globus sensations in the throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term efficiency of this treatment. To measure long term efficacy all patients treated with this therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient clinic of a university hospital
Key inclusion criteria (2 listed)
- former APC therapy of gastric inlet patches as treatment for globus sensations
- at least 6 month since last APC therapy
Key exclusion criteria (3 listed)
- patients with reduced general condition
- malignancy of the upper gastrointestinal tract
- patients older than 80 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of globus complaint score
Time frame: retrospectively assessed: before APC therapy and at the date of follow up
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 2 Jul 2013.
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.
Peter Klare, MD principal investigator
Departmet for Internal Medicine and Gastroenterology, Technical University Munich, Germany
Alexander Meining, Professor study chair
Department for Internal Medicine and Gastroenterology, Technical University Munich, Germany
Monther Bajbouj, Assistent Professor study director
Department for Internal Medicine and Gastroenterology, Technical University Munich, Germany
Questions about this trial
What is this clinical trial studying?
An observational study of Globus Sensations in the Throat, run by Technical University of Munich.
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 3 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 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of globus complaint score (time frame: retrospectively assessed: before APC therapy and at the date of follow up). 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 2 Jul 2013.