Gastroesophageal Reflux DiseaseNCT01110811
Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
A study testing Transoral Incisionless Fundoplication (TIF) in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by EndoGastric Solutions at 4 sites in 3 countries.
Trial summary
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Hiatal Hernia
- What is being tested?
- Transoral Incisionless Fundoplication (TIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Apr 2010to Dec 2018
- 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 18-80 years
- On daily PPIs for > 6 months
- Documented PPI dependency
- Persistent GERD symptoms without PPI therapy during the titration phase of the study
- Evidence of two or more of the following while off PPI therapy (> 10 days):
- Erosive esophagitis (Los Angeles grade A-C)
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- Abnormal ambulatory pH study
- Moderate to severe GERD symptoms
- Normal or near normal esophageal motility (by manometry)
- Patient willing to cooperate with post-operative dietary recommendations and assessment tests
- Signed informed consent
Who cannot join
- BMI > 35
- Hiatal hernia > 3 cm
- Esophagitis LA grade D
- Esophageal ulcer
- Esophageal stricture
- Barretts esophagus (Prague: C>1, M>2)
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- Esophageal motility disorder
- Severe gastric paralysis
- Pregnancy or plans for pregnancy in the next 12 months
- Immunosuppression
- ASA > 2
- Portal hypertension and/or varices
- History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
- Active gastro-duodenal ulcer disease
- Gastric outlet obstruction or stenosis
- Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment
- Coagulation disorders
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Sweden2 sites
Karolinska University, Ersta Hospital
Stockholm
Karolinska University, Huddinge Hospital
Stockholm
About this study
Official title: A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.
Read the detailed description
Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).
Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Being tested
- Transoral Incisionless Fundoplication (TIF)
- Keywords
- GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent
- Medical subject headings
- Gastroesophageal Reflux, Hernia, Hiatal, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Incisionless Fundoplication (TIF)Procedure or surgery
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.
| Study group | Role | What they receive |
|---|---|---|
| TIF procedure | Active comparator | Transoral Incisionless Fundoplication (TIF) Receives: Procedure: Transoral Incisionless Fundoplication (TIF) |
| Sham procedure | Sham comparator | The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy). Receives: Procedure: Transoral Incisionless Fundoplication (TIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in clinical remission
Fifty nine per cent of patients remained in clinical remission
Measured: at 6 month follow-up
Secondary outcomes (3)
Reduction in symptoms
GSRS score improved from 14 (range 10-21) to 10 (range 6-19) with P = 0.004.
Measured: at 6 moths follow-up
Normalized esophageal acid exposure
Sixty nine per cent of patients (69%) in TIF surgical arm normalized esophageal acid exposure.
Measured: at 6 months follow-up
Healed reflux esophagitis
In 80% of patients healing of esophagitis was observed
Measured: at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2015
- Study completionDec 2018
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoGastric Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars Lundell, M.D., Principal investigator, Karolinska University, Huddinge Hospital, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110811
- Sponsor's protocol ID
- D2009-10
- Status last verified
- Mar 2019
- First submitted
- 23 Apr 2010
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hakansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015 Dec;42(11-12):1261-70. doi: 10.1111/apt.13427. Epub 2015 Oct 13.
PubMed 26463242
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study
- ClinicalTrials.gov ID
- NCT01110811
- Acronym / sponsor ID
- D2009-10
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Keywords
- GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EndoGastric SolutionsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 Apr 2010 (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.
The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.
Detailed description
Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).
Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIF procedure | Active comparator | Procedure: Transoral Incisionless Fundoplication (TIF)Transoral Incisionless Fundoplication (TIF) |
| Sham procedure | Sham comparator | Procedure: Transoral Incisionless Fundoplication (TIF)The intervention on the Sham procedure consisted of an upper gastrointestinal endoscopy, or EGD.(esophagogastricduodenoscopy). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-80 years
- On daily PPIs for > 6 months
- Documented PPI dependency
- Persistent GERD symptoms without PPI therapy during the titration phase of the study
- Evidence of two or more of the following while off PPI therapy (> 10 days):
Key exclusion criteria (17 listed)
- BMI > 35
- Hiatal hernia > 3 cm
- Esophagitis LA grade D
- Esophageal ulcer
- Esophageal stricture
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 |
|---|---|---|
| Transoral Incisionless Fundoplication (TIF)The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus. | Procedure or surgery | Sham procedure, TIF procedure |
Primary outcome
Proportion of patients in clinical remission
Time frame: at 6 month follow-up
Fifty nine per cent of patients remained in clinical remission
3 secondary outcomes
Reduction in symptoms
Time frame: at 6 moths follow-up
Normalized esophageal acid exposure
Time frame: at 6 months follow-up
Healed reflux esophagitis
Time frame: at 6 months 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 6 Mar 2019.
- Derived from this study: PubMed 26463242Hakansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015 Dec;42(11-12):1261-70. doi: 10.1111/apt.13427. Epub 2015 Oct 13.
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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.
Lars Lundell, M.D. principal investigator
Karolinska University, Huddinge Hospital, Stockholm, Sweden
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral Incisionless Fundoplication (TIF) in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by EndoGastric Solutions at 4 sites in 3 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 11 inclusion and 17 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 6 Mar 2019. 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 Sweden, Belgium, France. 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. Some participants in this study may receive a placebo. 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?
Proportion of patients in clinical remission (time frame: at 6 month follow-up). 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 NCT01110811, 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 6 Mar 2019.