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

NCT ID: NCT01327963

Last Updated: 2020-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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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

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Gastroesophageal Reflux Disease (GERD)

Keywords

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Gastroesophageal reflux disease GERD Heartburn Reflux Regurgitation Hoarseness Cough

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transoral Incisionless Fundoplication

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.

Group Type EXPERIMENTAL

Transoral Incisionless Fundoplication

Intervention Type DEVICE

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.

Interventions

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Transoral Incisionless Fundoplication

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.

Intervention Type DEVICE

Other Intervention Names

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TIF

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EndoGastric Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Barnes, MD MBA FACS

Role: PRINCIPAL_INVESTIGATOR

Livingston Hospital and Healthcare Services Inc, CAH

Locations

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Munroe Regional Medical Center

Ocala, Florida, United States

Site Status

Livingston Hospital and Healthcare Services, Inc. CAH

Salem, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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D01079

Identifier Type: -

Identifier Source: org_study_id