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

Endogastric Solutions

Status: Terminated

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Device: Transoral Incisionless Fundoplication

Study type: Interventional

Funder types: Industry

Identifiers

NCT01327963

D01079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Transoral Incisionless Fundoplication

Experimental group

Description:

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.

Treatment:

Device: Transoral Incisionless Fundoplication