Gastroesophageal Reflux DiseaseNCT01118585
Transoral Incisionless Fundoplication (TIF) Registry Study for Treatment of Gastroesophageal Reflux Disease (GERD)
A study testing TIF Procedure in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by EndoGastric Solutions at 14 sites in United States.
Trial summary
The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Hiatal Hernia
- What is being tested?
- TIF Procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 14 sitesUnited States
- Study dates
- May 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- GERD for > 1 year
- History of daily PPIs use for > 6 months
- Moderate to severe typical or atypical GERD symptoms off PPIs
- Complete (responders) or partial (nonresponders) symptom control on PPIs
- Deteriorated gastroesophageal junction (Hill grade II or III)
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- Proven gastroesophageal reflux by either endoscopy, ambulatory pH or barium swallow testing
- Willingness to undergo pH/impedance testing, if required
- Willingness to cooperate with the postoperative diet for 6 weeks
- Availability for follow up visits at 6 months and 12 months
- Willingly and cognitively signed informed consent
Who cannot join
- BMI > 35
- Incompletely reducible hiatal hernia with residual of > 5 mm
- Esophagitis grade D
- Barrett's Esophagus > 2 cm
- Esophageal ulcer
- Fixed esophageal stricture or narrowing
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- Portal hypertension and/or varices
- Active gastro-duodenal ulcer disease
- Gastric outlet obstruction or stenosis
- Gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study, if patient complains of postprandial satiety during assessment
- Coagulation disorder
- History of any of the following: resective gastric or esophageal surgery, antireflux surgery with anatomy unsuitable for TIF procedure per physician judgment, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis
- Pregnancy or plans of pregnancy in the next 12 months
- Enrollment in another device or drug study that may confound the results
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Allegan Surgical Associates
Allegan, Michigan, 49010
Ihde Surgical Group, PA
Arlington, Texas, 76014
The Surgeons Group of Baton Rouge
Baton Rouge, Louisiana, 70808
Crossville Medical Group
Crossville, Tennessee, 38555
Swedish Medical Center and SurgOne P.C.
Englewood, Colorado, 80110
St Mary's Hospital
Hobart, Indiana, 46342
The University of Texas Health Science Center
Houston, Texas, 77030
Munroe Regional Hospital
Ocala, Florida, 34471
Utah County Surgical Associates
Provo, Utah, 84604
Reston Hospital
Reston, Virginia, 20190
Mt. Graham Regional Medical Center
Safford, Arizona, 85546
Livingston Hospital and Healthcare Services, Inc. CAH
Salem, Kentucky, 42078
Master Center for Minimally Invasive Surgery
Southlake, Texas, 76092
Tempe St. Luke's Hospital
Tempe, Arizona, 85281
About this study
Official title: Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
The study objective is to evaluate the safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
Read the detailed description
Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.
Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Being tested
- TIF Procedure
- 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.
TIF ProcedureProcedure or surgery
Also called TIF - Transoral Incisionless fundoplication
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.
| Study group | Role | What they receive |
|---|---|---|
| TIF Procedure | Other | Intervention: Transoral incisionless fundoplication procedure using the EsophyX device. During general anesthesia the EsophyX device is introduced trans orally into the stomach and used to created a 270 degree, 3cm in length, wrap at the distal end of the esophagus to treat GERD.. . Receives: Procedure: TIF Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroesophageal Reflux Disease (GERD) symptom elimination
GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index).
Measured: 6-month follow-up
Secondary outcomes (5)
Elimination of Proton Pump Inhibitor (PPI) usage
Elimination of Proton Pump Inhibitor (PPI) usage
Measured: at 12-, 24- and 36-month follow-up
Esophageal acid exposure
Normalization of esophageal acid exposure is defined as ≤ 4.3% of 24-hour period or ≤ 5.3% of 48-hour period at pH < 4.
Measured: at 6-, 12-, 24- and 36-month follow-up
Healing of reflux esophagitis
Healing of reflux esophagitis
Measured: at 12, 24- and 36-month follow-up
Safety outcomes
Incidence of anticipated and unanticipated adverse events
Measured: first 30 days
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
GERD symptom elimination based on GERD-HRQL, GSRS and RSI scores.
Measured: at 12-, 24- and 36-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 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2015
- Study completionDec 2018
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
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoGastric Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reginald CW Bell, MD, FACS, Principal investigator, SurgOne P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118585
- Sponsor's protocol ID
- D00960
- Status last verified
- Mar 2019
- First submitted
- 30 Apr 2010
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- Prospective Outcome Evaluation of Transoral Incisionless Fundoplication (TIF) for the Treatment of Gastroesophageal Reflux Disease (GERD): The TIF Registry Study
- ClinicalTrials.gov ID
- NCT01118585
- Acronym / sponsor ID
- D00960
- Conditions
- Gastroesophageal Reflux Disease, Hiatal Hernia
- Keywords
- GERD, Esophagitis, Fundoplication, Anti-reflux surgery, PPI dependent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- EndoGastric SolutionsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 May 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 safety and efficacy of TIF among a broad range of GERD patients treated in routine clinical practice at multiple centers across the United States.
Detailed description
Primary Effectiveness Endpoint: Typical and atypical GERD symptom elimination (scores ≤ 2 to each question) or clinically significant improvement (≥ 50% reduction in total scores) at 6-month follow-up compared to baseline.
Secondary Effectiveness Endpoints: GERD symptom elimination or clinically significant improvement at 12-month follow-up, 24-month follow-up and 36-month follow-up; complete discontinuation of PPIs; normalization of esophageal acid exposure; significant reduction in reflux episodes; healing of reflux esophagitis; reduction of hiatal hernia; safety supported by low incidence of serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIF Procedure | Other | Procedure: TIF ProcedureIntervention: Transoral incisionless fundoplication procedure using the EsophyX device. During general anesthesia the EsophyX device is introduced trans orally into the stomach and used to created a 270 degree, 3cm in length, wrap at the distal end of the esophagus to treat GERD.. . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 years
- GERD for > 1 year
- History of daily PPIs use for > 6 months
- Moderate to severe typical or atypical GERD symptoms off PPIs
- Complete (responders) or partial (nonresponders) symptom control on PPIs
Key exclusion criteria (14 listed)
- BMI > 35
- Incompletely reducible hiatal hernia with residual of > 5 mm
- Esophagitis grade D
- Barrett's Esophagus > 2 cm
- Esophageal ulcer
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 |
|---|---|---|
| TIF ProcedureAlso: TIF - Transoral Incisionless fundoplicationThe TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus. | Procedure or surgery | TIF Procedure |
Primary outcome
Gastroesophageal Reflux Disease (GERD) symptom elimination
Time frame: 6-month follow-up
GERD symptoms (typical and atypical) will be evaluated using three disease-specific standardized questionnaires: GERD-HRQL (Health-related Quality of Life), GSRS (GERD Symptom Rating Score), and RSI (Reflux Symptom Index).
5 secondary outcomes
Elimination of Proton Pump Inhibitor (PPI) usage
Time frame: at 12-, 24- and 36-month follow-up
Esophageal acid exposure
Time frame: at 6-, 12-, 24- and 36-month follow-up
Healing of reflux esophagitis
Time frame: at 12, 24- and 36-month follow-up
Safety outcomes
Time frame: first 30 days
Long-term Gastroesophageal Reflux Disease (GERD) symptom elimination
Time frame: at 12-, 24- and 36-month 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.
- Click here for more information about this study: TIF Registry studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Reginald CW Bell, MD, FACS principal investigator
SurgOne P.C.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIF Procedure in people with Gastroesophageal Reflux Disease and Hiatal Hernia, run by EndoGastric Solutions at 14 sites in United States.
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 14 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 14 sites in United States. 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?
Gastroesophageal Reflux Disease (GERD) symptom elimination (time frame: 6-month 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 6 Mar 2019.