Gastroesophageal Reflux Disease (GERD)Phase 3TvPNCT00857597
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
A Phase 3 study testing Transoral Incisionless Fundoplication in people with Gastroesophageal Reflux Disease (GERD), run by University of Pittsburgh at 1 site in Netherlands.
Trial summary
The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Transoral Incisionless Fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Proven gastroesophageal reflux (pH < 4 for > 4.3% time while off PPIs for 7-14 days)
- On daily PPIs for > 1 year
- Recurrence of GERD symptoms (GERD-HRQL score difference of > 10 between on and off PPIs)
- Normal or hypotonic LES resting pressure (5-40 mmHg)
- Patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol
- Signed informed consent
Who cannot join
- BMI > 35
- Hiatal hernia > 2 cm
- Esophagitis grade D
- Barrett's esophagus
- Esophageal stricture
- Esophageal ulcer
Show all 18Show fewer
- Esophageal motility disorder
- Gastric motility disorder
- Prior splenectomy
- Gastric paralysis
- Pregnancy (in females)
- Immunosuppression
- ASA > 2
- Portal hypertension
- Coagulation disorders
- Previous antireflux procedure
- Any other health condition, which the investigator believes would prevent the patient from completing the study
- Lack of fluency in English
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Hospital Maastricht
Maastricht, Limburg, 6229 HX
About this study
Official title: A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Transoral Incisionless Fundoplication, Proton Pump Inhibitors; active control
- Keywords
- GERD, endoscopic, fundoplication, Proton Pump Inhibitors, heartburn, anti-reflux surgery
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Incisionless FundoplicationProcedure or surgery
Also called TIF procedure, ELF procedure, Endoluminal fundoplication, Endoscopic fundoplication
The TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference.
Proton Pump Inhibitors; active controlDrug
Also called Esomeprazole, Lansomeprazole, Omeprazole, Pantoprazole
Proton Pump Inhibitors; active control
| Study group | Role | What they receive |
|---|---|---|
| EsophyX | Experimental | Not described Receives: Procedure: Transoral Incisionless Fundoplication |
| Proton Pump Inhibitors | Active comparator | Not described Receives: Drug: Proton Pump Inhibitors; active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD symptoms
Measured: Baseline
GERD symptoms
Measured: 6 month follow-up
GERD symptoms
Measured: 12 month follow-up
Secondary outcomes (4)
PPI usage
Measured: at 0, 6 and 12 month follow- up
Lower esophageal acid exposure
Measured: at 0, 6 and 12 month follow- up
Esophagitis
Percentage of Participants with Esophagitis (Los Angeles classification scale)
Measured: at 0, 6 and 12 month follow- up
Rate of adverse events
Measured: at 0, 6 and 12 month follow- up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Study was terminated after unplanned interim analysis of single centre data and results were reported
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- EndoGastric Solutions, Sandhill Scientific, Crospon
- Responsible party
- Sponsor
- Investigators
- Blair A Jobe, MD, Principal investigator, University of Pittsburgh Medical CenterNicole D Bouvy, MD, PhD, Principal investigator, University Hospital Maastricht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857597
- Sponsor's protocol ID
- D00668-01C
- Other IDs
- PRO08110069
- Acronym
- TvP
- Status last verified
- Oct 2016
- First submitted
- 4 Mar 2009
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Transoral Incisionless Fundoplication (TIF) Versus Proton Pump Inhibitors (PPIs) for Treatment of GERD: The TIF vs. PPIs Study
- ClinicalTrials.gov ID
- NCT00857597
- Acronym / sponsor ID
- TvP / D00668-01C
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GERD, endoscopic, fundoplication, Proton Pump Inhibitors, heartburn, anti-reflux surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated after unplanned interim analysis of single centre data and results were reported
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- EndoGastric Solutions, Sandhill Scientific, Crospon
- Study start
- Mar 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Mar 2009 (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 GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EsophyX | Experimental | Procedure: Transoral Incisionless Fundoplication |
| Proton Pump Inhibitors | Active comparator | Drug: Proton Pump Inhibitors; active control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years
- Proven gastroesophageal reflux (pH < 4 for > 4.3% time while off PPIs for 7-14 days)
- On daily PPIs for > 1 year
- Recurrence of GERD symptoms (GERD-HRQL score difference of > 10 between on and off PPIs)
- Normal or hypotonic LES resting pressure (5-40 mmHg)
Key exclusion criteria (18 listed)
- BMI > 35
- Hiatal hernia > 2 cm
- Esophagitis grade D
- Barrett's esophagus
- 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 FundoplicationAlso: TIF procedure, ELF procedure, Endoluminal fundoplication, Endoscopic fundoplicationThe TIF procedure using the EsophyX system with SerosaFuse fasteners was designed to create full-thickness serosa-to-serosa plications and construct valves of 3-5 cm in length and 200-300° in circumference. | Procedure or surgery | EsophyX |
| Proton Pump Inhibitors; active controlAlso: Esomeprazole, Lansomeprazole, Omeprazole, PantoprazoleProton Pump Inhibitors; active control | Drug | Proton Pump Inhibitors |
Primary outcome
GERD symptoms
Time frame: Baseline
GERD symptoms
Time frame: 6 month follow-up
GERD symptoms
Time frame: 12 month follow-up
4 secondary outcomes
PPI usage
Time frame: at 0, 6 and 12 month follow- up
Lower esophageal acid exposure
Time frame: at 0, 6 and 12 month follow- up
Esophagitis
Time frame: at 0, 6 and 12 month follow- up
Rate of adverse events
Time frame: at 0, 6 and 12 month follow- up
Results and safety
The study was stopped early (reason given: Study was terminated after unplanned interim analysis of single centre data and results were reported). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Data reported in Am J Gastroenterol. 2015 Apr;110(4):531-42. doi: 10.1038/ajg.2015.28. Epub 2015 Mar 31.Link provided by the sponsor.
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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.
Blair A Jobe, MD principal investigator
University of Pittsburgh Medical Center
Nicole D Bouvy, MD, PhD principal investigator
University Hospital Maastricht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transoral Incisionless Fundoplication in people with Gastroesophageal Reflux Disease (GERD), run by University of Pittsburgh at 1 site in Netherlands.
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 7 inclusion and 18 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: stopped early, as of the sponsor's last update on 30 Mar 2018. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated after unplanned interim analysis of single centre data and results were reported). Results are not available in the source record.
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?
GERD symptoms (time frame: Baseline). The study lists 3 primary outcomes in all. 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 30 Mar 2018.