Gastroesophageal Reflux Disease (GERD)RetroTIFNCT01327963

Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study

A study testing Transoral Incisionless Fundoplication in people with Gastroesophageal Reflux Disease (GERD), run by EndoGastric Solutions at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Gastroesophageal Reflux Disease (GERD)
What is being tested?: Transoral Incisionless Fundoplication
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 2 sitesUnited States
Study dates: Sep 2010to Feb 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-85 years
Have undergone the TIF procedure within the past 2 years
History of daily proton pump inhibitor (PPI) use for >6 months
Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs
Deteriorated gastroesophageal junction (Hill grade II or III)
Availability for a follow-up visit at 6,12 or 24 months
Willingly and cognitively signed informed consent

Who cannot join

Procedure not completed or performed following a non-standardized TIF protocol
Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease
Pregnancy
Enrollment in another device or drug study that may confound the results

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Munroe Regional Medical Center
Ocala, Florida, 34471
Livingston Hospital and Healthcare Services, Inc. CAH
Salem, Kentucky, 42078

Other trials in United States

About this study

Official title: Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study

Read the detailed description

This retrospective, open-label, post-market study evaluates the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States, in clinical routine practice, as standard of care.

Conditions: Gastroesophageal Reflux Disease (GERD)
Being tested: Transoral Incisionless Fundoplication
Keywords: Gastroesophageal reflux disease, GERD, Heartburn, Reflux, Regurgitation, Hoarseness, Cough
Medical subject headings: Gastroesophageal Reflux, Heartburn, Hoarseness, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transoral Incisionless FundoplicationDevice
Also called TIF
Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.

Study groups in NCT01327963
Study group	Role	What they receive
Transoral Incisionless Fundoplication	Experimental	Intervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0). With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro-esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GastroEsophageal Junction (GEJ) below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications. Receives: Device: Transoral Incisionless Fundoplication

What is being measured

The primary outcome is the main question the study is designed to answer.

Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of <18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of < or = 13) questionnaires) at the follow-up.
Measured: median 7 months (range 5-17 months)

Secondary outcomes (5)

Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)
The treatment will be considered safe if the incidence of serious adverse events (SAEs) is below the ranges reported for laparoscopic fundoplication.
Measured: median 7 months (range 5-17 months)
Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use
Patients reporting complete discontinuation of daily PPI use will be considered clinically significant.
Measured: median 7 months (range 5-17 months)
Number of Participants With Healing of Reflux Esophagitis
One LA grade reduction will be considered clinically significant. LA grades are A, B, C, D, with A being the least severe esophagitis. No grade assigned is considered "normal", i.e. no esophagitis reported.
Measured: median 7 months (range 5-17 months)
Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up
Measurement obtained by study investigator, under endoscopic visualization using cm markings on the endoscope. Outcome measure assesses if hiatal hernia that was present at baseline and reduced (size reduction to < 1 cm is considered clinically significant) during TIF procedure, has remained reduced at the post-TIF follow up exam.
Measured: median 7 months (range 5-17 months)
Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes
Esophageal acid exposure will be measured objectively by 48-hour Bravo Potential of Hydrogen (pH) or 24-hour impedance/pH testing at the follow-up (where pH testing is available). Normalization of esophageal acid exposure will be defined by total time pH< 4 for ≤ 6% of 24-hour or for ≤ 5.3% of 48-hour monitoring period. The number of reflux episodes of ≤ 44 per each 24-hour period will be considered normal.
Measured: median 7 months (range 5-17 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Feb 2014

First posted4 Apr 2011 (estimated)
Study startSep 2010
Primary completionFeb 2014
Study completionFeb 2014

Why it stopped: The sponsor is focusing on prospective randomized studies

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastroesophageal Reflux Disease (GERD)Studies 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: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01327963
Sponsor's protocol ID: D01079
Acronym: RetroTIF
Status last verified: Nov 2020
First submitted: 30 Mar 2011
Last updated: 3 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
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Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
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Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
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Recruiting
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Paraesophageal Hernia, GERD

All Gastroesophageal Reflux Disease (GERD) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Outcomes After Transoral Incisionless Fundoplication (TIF) Performed in Routine Clinical Practice: The Retro TIF Study
ClinicalTrials.gov ID: NCT01327963
Acronym / sponsor ID: RetroTIF / D01079
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal reflux disease, GERD, Heartburn, Reflux, Regurgitation, Hoarseness, Cough
Study type: Interventional
Recruitment status: TerminatedReason stopped: The sponsor is focusing on prospective randomized studies
Enrolment: 110 participants (actual)
Lead sponsor: EndoGastric SolutionsIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 4 Apr 2011 (estimated)
Results: Posted 3 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Transoral Incisionless Fundoplication	Experimental	Device: Transoral Incisionless FundoplicationIntervention: Transoral Incisionless Fundoplication 2.0 technique iteration (TIF 2.0). With patient in general anesthesia. The EsophyX (brand name) device is introduced through the mouth, over a standard endoscope, into the stomach. Multiple gastro-esophageal plications are performed, apposing the fundus to the distal part of the esophagus and repositioning the GastroEsophageal Junction (GEJ) below the diaphragm, into the abdomen. Multiple prolene fasteners are used to secure and keep in place the plications.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 18-85 years
Have undergone the TIF procedure within the past 2 years
History of daily proton pump inhibitor (PPI) use for >6 months
Proven gastroesophageal reflux by either endoscopy, ambulatory potential of hydrogen (pH) or moderate to severe symptoms on or off PPIs
Deteriorated gastroesophageal junction (Hill grade II or III)

Key exclusion criteria (4 listed)

Procedure not completed or performed following a non-standardized TIF protocol
Subjects suffering from other gastrointestinal (GI) conditions such as dyspepsia, celiac disease, Irritable bowel syndrome (IBS) or Crohn's disease
Pregnancy
Enrollment in another device or drug study that may confound the results

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: TIFTransoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.	Device	Transoral Incisionless Fundoplication

Primary outcome

Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination
Time frame: median 7 months (range 5-17 months)
Typical and atypical GERD symptom elimination in GERD Health-Related Quality of Life (GERD-HRQL). HRQL questionnaire measures typical GERD symptoms, scale 0-5 for each of 9 questions; scores considered normalized if every score is 0), GERD Symptom Score (GERSS measures atypical GERD symptoms, scale 0-3 for severity and 0-4 for frequency, with total scale 0-60; patients with controlled reflux symptoms are expected to have a score of <18) and Reflux Symptom Index (RSI measures atypical laryngopharyngeal (LPR) symptoms, scale 0-5 for each of 9 questions with maximum of 45 with a normality threshold of < or = 13) questionnaires) at the follow-up.

5 secondary outcomes

Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)
Time frame: median 7 months (range 5-17 months)
Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use
Time frame: median 7 months (range 5-17 months)
Number of Participants With Healing of Reflux Esophagitis
Time frame: median 7 months (range 5-17 months)
Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up
Time frame: median 7 months (range 5-17 months)
Number of Participants With Normalization or Clinically Significant Improvement in Esophageal Acid Exposure Assessed by Impedance/pH Testing and Reflux Episodes
Time frame: median 7 months (range 5-17 months)

Results and safety

Results posted to the registry on 3 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transoral Incisionless Fundoplication	110	110

Primary outcome: Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination

Time frame: median 7 months (range 5-17 months). Count of participants. Unit: Participants

Measure	Transoral Incisionless Fundoplication n = 110
Participants with normal GERD-HRQL scores	88
Participants with controlled reflux symptoms measured by GERSS questionnaire	87
Patients scoring in the normality threshold on RSI questionnaire	83

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: This is a retrospective study. TIF procedures were performed from November 2008 through December 2009. The study enrolled patients and collected post-TIF follow up visits in 2010. Adverse event data was collected from day of TIF procedure through final follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transoral Incisionless Fundoplication	0 of 110 (0%)	0 of 110 (0%)	0 of 110

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Gastroesophageal Reflux Disease (GERD)

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
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Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
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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.

William Barnes, MD MBA FACS principal investigator

Livingston Hospital and Healthcare Services Inc, CAH

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transoral Incisionless Fundoplication in people with Gastroesophageal Reflux Disease (GERD), run by EndoGastric Solutions at 2 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 7 inclusion and 4 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 3 Dec 2020. 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 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?

Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Typical and Atypical Gastroesophageal Reflux Disease (GERD) Symptom Elimination (time frame: median 7 months (range 5-17 months)). 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 NCT01327963.

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 3 Dec 2020.