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

NCT01327963 | Terminated Results

• 1 other identifier: D01079
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

Gastroesophageal reflux disease; GERD; Heartburn; Reflux; Regurgitation; Hoarseness; Cough

Outcome Measures

Primary Outcomes (1)

• 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.

  median 7 months (range 5-17 months)

Secondary Outcomes (5)

• Number of Participants Experiencing Serious Adverse Events (SAEs) & Unanticipated Adverse Device Effects (UADEs)

  median 7 months (range 5-17 months)

• Number of Participants Reporting Complete Elimination of Proton Pump Inhibitor (PPI) Use

  median 7 months (range 5-17 months)

• Number of Participants With Healing of Reflux Esophagitis

  median 7 months (range 5-17 months)

• Number of Participants Whose Baseline Hiatal Hernia Has Remained Reduced at Post-TIF Follow-up

  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

  median 7 months (range 5-17 months)

Study Arms (1)

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.

Device: Transoral Incisionless Fundoplication

Interventions

Transoral Incisionless Fundoplication 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.

Also known as: TIF

Transoral Incisionless Fundoplication

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EndoGastric Solutions: lead

Study Sites (2)

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Livingston Hospital and Healthcare Services, Inc. CAH

Salem, Kentucky, 42078, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Hoarseness; Cough

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms, Respiratory

Results Point of Contact

• Title: Adrian Lobontiu, Chief Medical Officer
• Organization: EndoGastric Solutions

alobontiu@endogastricsolutions.com

1 650-474-9259

Study Officials

• William Barnes, MD MBA FACS

  Livingston Hospital and Healthcare Services Inc, CAH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 4, 2011
• Study Start: September 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)